(a) Except as otherwise specifically provided these Rules
apply to all persons who receive, possess, use, transfer, own or acquire any
source of radiation within the State of North Carolina.

(b) Nothing in these Rules shall apply to any person to the
extent any person is subject to regulation by the United States Nuclear
Regulatory Commission.

(c) Regulation by the State of North Carolina of source
material, byproduct material, and special nuclear material in quantities not
sufficient to form a critical mass is subject to the provisions of the
"Agreement Between the United States Atomic Energy Commission and the
State of North Carolina for Discontinuance of Certain Commission Regulatory and
Responsibility within the State Pursuant to Section 274 of the Atomic Energy
Act of 1954, as Amended" under provisions of Public Law 86-373, as
amended, and 10 CFR Part 150.

(8) "Air-purifying respirator" means a
respirator with an air-purifying filter, cartridge, or canister that removes
specific air contaminants by passing ambient air through the air-purifying
element.

(9) "Airborne radioactive material" means any
radioactive material dispersed in the air in the form of dusts, fumes,
particulates, mists, vapors, or gases.

(10) "Airborne radioactivity area" means a
room, enclosure, or area in which airborne radioactive materials, composed
wholly or partly of licensed radioactive material, exist in concentrations:

(a) in excess of the derived air concentrations specified
in Appendix B to 10 CFR 20.1001 - 20.2401; or

(b) to such a degree that an individual present
in the area without respiratory protective equipment could exceed, during the
hours an individual is present in a week, an intake of 0.6 percent of the
annual limit on intake or 12 DAC-hours.

(11) "ALARA" (acronym for "as low as is
reasonably achievable") means making every reasonable effort to maintain
exposures to radiation as far below the dose limits in the rules of this
Chapter as is practical consistent with the purpose for which the licensed or
registered activity is undertaken, taking into account the state of technology,
the economics of improvements in relation to benefits to the public health and
safety, and other societal and socioeconomic considerations, and in relation to
utilization of sources of radiation in the public interest.

(12) "Annual limit on intake" (ALI) means the
derived limit for the amount of radioactive material taken into the body of an
adult worker by inhalation or ingestion in a year. ALI is the smaller value of
intake of a given radionuclide in an effective dose equivalent of five rems
(0.05 Sv) or a committed dose equivalent of 50 rems (0.5 Sv) to any individual
organ or tissue. The ALI values for intake by ingestion and by inhalation of
selected radionuclides are given in Table 1, Columns 1 and 2, of Appendix B to
10 CFR 20.1001 - 20.2401.

(13) "Annually" means either:

(a) at intervals not to exceed 12 consecutive
months; or

(b) once per year at the same time each year
(completed during the same month each year over a period of multiple years).

(14) "Assigned protection factor (APF)" means
the expected workplace level of respiratory protection that would be provided
by a properly functioning respirator or a class of respirators to properly
fitted and trained users. APF can be divided into the ambient airborne
concentrations to estimate inhaled air concentrations.

(15) "Atmosphere-supplying respirator" means a
respirator that supplies the respirator user with breathing air from a source
independent of the ambient atmosphere and includes supplied-air respirators and
self-contained breathing apparatus units.

(16) "Authorized representative" means an
employee of the agency, or an individual outside the agency when the individual
is so designated by the agency under Rule .0112 of this Section.

(17) "Authorized user" means an individual who
is authorized by license or registration condition to use a source of
radiation.

(18) "Background radiation" means radiation
from cosmic sources; naturally occurring radioactive materials, including radon
(except as a decay product of source or special nuclear material); and global
fallout as it exists in the environment from the testing of nuclear explosive
devices or from past nuclear accidents such as Chernobyl that are not under the
control of the licensee or registrant. "Background radiation" does
not include sources of radiation regulated by the agency.

(19) "Becquerel" is the SI unit of
radioactivity. One becquerel is equal to one disintegration per second (s-1).

(20) "Bioassay" or "radiobioassay"
means the determination of kinds, quantities or concentrations, and, in some
cases, the locations of radioactive material in the human body, whether by
direct measurement (in vivo counting) or by analysis and evaluation of
materials excreted or removed from the human body.

(21) "Brachytherapy" means a method of
radiation therapy in which sources are used to deliver a radiation dose at a
distance of up to a few centimeters by surface, intracavitary, intraluminal or
interstitial application.

(22) "Brachytherapy source" means a radioactive
source or a manufacturer assembled source train or a combination of these
sources that is designed to deliver a therapeutic dose within a distance of a few
centimeters.

(23) "Byproduct material" has the meaning as
defined in G.S. 104E-5(4), and in addition includes:

(a) The tailings or wastes produced by the
extraction or concentration of uranium or thorium from ore processed primarily
for its source material content, including discrete surface wastes resulting
from uranium solution extraction processes. Underground ore bodies depleted by
these solution extraction operations do not constitute "byproduct material"
within this definition;

(b) Any discrete source of Radium-226 that is
produced, extracted, or converted after extraction, for use for a commercial,
medical, or research activity;

(c) Any material that:

(i) has been made radioactive by use of a
particle accelerator; or

(ii) is produced, extracted, or converted after
extraction, for use for a commercial, medical, or research activity; and

(i) the US Nuclear Regulatory Commission, in
consultation with the Administrator of the Environmental Protection, the
Secretary of Energy, the Secretary of Homeland Security, and the head of any
other appropriate federal agency, determines would poses a threat similar to
the threat posed by a discrete source of radium-226 to the public health and
safety or the common defense and security; and

(ii) is extracted or converted after extraction
for use in a commercial, medical, or research activity.

(24) "Class", "lung class" or
"inhalation class" means a classification scheme for inhaled material
according to its rate of clearance from the pulmonary region of the lung.
Materials are classified as D, W, or Y, which applies to a range of clearance
half-times as follows:

CLASSIFICATION OF
INHALED MATERIAL

Class Clearance
half-time

Class D (Day) less
than 10 days

Class W (Weeks) 10
days to 100 days

Class Y (Years) greater
than 100 days

(25) "Clinical procedures manual" means a
collection of procedures governing the medical use of radioactive material not
requiring a written directive that describes each method by which the licensee
performs clinical procedures and includes other instructions and precautions.
Each clinical procedure, including the radiopharmaceutical dosage and route of
administration, shall be approved in writing by an authorized user prior to
inclusion in the manual. The radiation safety officer shall ensure that the
manual includes the approved procedure(s) for all clinical procedures using
radioactive material not requiring a written directive performed at the
facility.

(26) "Collective dose" is the sum of the
individual doses received in a given period of time by a specified population
from exposure to a specified source of radiation.

(27) "Commission" has the meaning as defined in
G.S. 104E-5(5).

(28) "Committed dose equivalent" (HT,50)
means the dose equivalent to organs or tissues of reference (T) that will be
received from an intake of radioactive material by an individual during the
50-year period following the intake.

(29) "Committed effective dose equivalent" (HE,50)
is the sum of the products of the weighting factors applicable to each of the
body organs or tissues that are irradiated and the committed dose equivalent to
these organs or tissues (HE,50 = ΣwTHT,50).

(30) "Consortium" means an association of
medical use licensees and a PET radionuclide production facility that jointly
own or share in the operation and maintenance costs of the PET radionuclide
production facility that produces PET radionuclides for use in producing
radioactive drugs within the consortium for noncommercial distributions among
its associated members for medical use. The consortium's PET radionuclide
production facility must be located at an educational institution, federal or
medical facility.

(32) "Controlled area" means an area, outside
of a restricted area but inside the site boundary, access to which can be
limited by the licensee or registrant for any reason.

(33) "Critical group" means the group of
individuals reasonably expected to receive the greatest exposure to residual
radioactivity for any applicable set of circumstances.

(34) "Curie" is the special unit of
radioactivity. One curie is equal to 3.7 x 1010 disintegrations per
second = 3.7 x 1010 becquerels = 2.22 x 1012
disintegrations per minute.

(35) "Declared pregnant woman" means a woman
who has voluntarily informed the licensee or registrant, in writing, of her
pregnancy and the estimated date of conception. The declaration remains in
effect until the declared pregnant woman withdraws the declaration in writing
or is no longer pregnant.

(36) "Decommission" means to remove (as a
facility) safely from service and reduce residual radioactivity to a level that
permits release of the property for either unrestricted use and termination of
the license or for restricted use and termination of the license.

(37) "Deep-dose equivalent" (Hd),
which applies to external whole-body exposure, is the dose equivalent at a
tissue depth of one cm (1000 mg/cm2).

(38) "Demand respirator" means an
atmosphere-supplying respirator that admits breathing air to the facepiece only
when a negative pressure is created inside the facepiece by inhalation.

(39) "Department" has the meaning as defined in
G.S. 104E-5(6).

(40) "Depleted uranium" means the source
material uranium in which the isotope uranium-235 is less than 0.711 weight
percent of the total uranium present. Depleted uranium does not include special
nuclear material.

(41) "Derived air concentration" (DAC) means
the concentration of a given radionuclide in air which, if breathed by the
reference man for a working year of 2,000 hours under conditions of light work
(inhalation rate 1.2 cubic meters of air per hour), results in an intake of
ALI. DAC values are given in Table 1, Column 3, of Appendix B to 10 CFR
20.1001 - 20.2401).

(42) "Derived air concentration-hour"
(DAC-hour) is the product of the concentration of radioactive material in air
(expressed as a fraction or multiple of the derived air concentration for each
radionuclide) and the time of exposure to that radionuclide, in hours. A
licensee may take 2,000 DAC-hours to represent one ALI, equivalent to a
committed effective dose equivalent of five rems (0.05 Sv).

(43) "Discrete source" means a radionuclide
that has been processed so that its concentration within a material has been
purposely increased for use for commercial, medical, or research activities.

(44) "Disposable respirator" means a respirator
for which maintenance is not intended and that is designed to be discarded
after excessive breathing resistance, sorbent exhaustion, physical damage, or
end-of-service-life renders it unsuitable for use. Examples of this type of
respirator are a disposable half-mask respirator or a disposable escape-only
self-contained breathing apparatus (SCBA).

(45) "Distinguishable from background" means
that the detectable concentration of a radionuclide is statistically different
from the background concentration of that radionuclide in the vicinity of the
site or, in the case of structures, in similar materials using measurement
technology, survey and statistical techniques as defined in 10 CFR 20.1003.

(46) "Dose" or "radiation dose" is a
generic term that means absorbed dose, dose equivalent, effective dose
equivalent, committed dose equivalent, committed effective dose equivalent, or
total effective dose equivalent, as defined in other Items of this Rule.

(47) "Dose equivalent" (HT) means
the product of the absorbed dose in tissue, quality factor, and all other
necessary modifying factors at the location of interest. The units of dose
equivalent are the rem and sievert (Sv).

(48) "Dose limits" (see "Limits"
defined in this Rule).

(49) "Dosimetry processor" means an individual
or organization that processes and evaluates individual monitoring equipment in
order to determine the radiation dose delivered to the equipment.

(50) "Effective dose equivalent" (HE)
is the sum of the products of the dose equivalent to the organ or tissue (HT)
and the weighting factors (wT)
applicable to each of the body organs or tissues that are irradiated (HE
= ΣwTHT).

(51) "Embryo/fetus" means the developing human
organism from conception until the time of birth.

(52) "Entrance or access point" means any
location through which an individual could gain access to radiation areas or to
a source of radiation. This includes entry or exit portals of sufficient size
to permit human entry, irrespective of their intended use.

(53) "Equipment services" means the selling,
installation, rebuilding, conversion, repair, inspection, testing, survey or
calibration of equipment which can affect compliance with these Rules by a
licensee or registrant.

(54) "Exposure" means being exposed to ionizing
radiation or to radioactive material.

(55) "Exposure rate" means the exposure per
unit of time, such as R/min and mR/h.

(56) "External dose" means that portion of the
dose equivalent received from radiation sources outside the body.

(59) "Filtering facepiece" or "dust
mask" means a negative pressure particulate respirator with a filter as an
integral part of the facepiece or with the entire facepiece composed of the
filtering medium, not equipped with elastomeric sealing surfaces and adjustable
straps.

(60) "Fit factor" means a quantitative estimate
of the fit of a particular respirator to a specific individual, and typically
estimates the ratio of the concentration of a substance in ambient air to its
concentration inside the respirator when worn.

(61) "Fit test" means the use of a protocol to
qualitatively or quantitatively evaluate the fit of a respirator on an
individual.

(62) "Generally applicable environmental radiation
standards" means standards issued by the U.S. Environmental Protection
Agency (EPA) under the authority of the Atomic Energy Act of 1954 (42 U.S.C.
2011 et seq.), as amended, that impose limits on radiation exposures or
levels, or concentrations or quantities of radioactive material, in the general
environment outside the boundaries of locations under the control of persons
possessing or using sources of radiation.

(63) "Gray" (Gy) is the SI unit of absorbed
dose. One gray is equal to an absorbed dose of one joule/kilogram (100 rads).

(64) "Helmet" means a rigid respiratory inlet
covering that also provides head protection against impact and penetration.

(65) "High dose-rate remote afterloader" (HDR)
means a brachytherapy device that remotely delivers a dose rate in excess of 12
gray (1200 rads) per hour at the point or surface where the dose is prescribed.

(66) "High radiation area" means an area,
accessible to individuals, in which radiation levels from sources external to
the body could result in an individual receiving a dose equivalent in excess of
0.1 rem (1 mSv) in one hour at 30 centimeters from the radiation source or from
any surface that the radiation penetrates.

(67) "Hood" means a respiratory inlet covering
that completely covers the head and neck and may also cover portions of the
shoulders and torso.

(68) "Hospital" means a facility that provides
as its primary functions diagnostic services and intensive medical and nursing
care in the treatment of acute stages of illness.

(a) the assessment of dose equivalent by the use
of devices designed to be worn by an individual;

(b) the assessment of committed effective dose
equivalent by bioassay or by determination of the time-weighted air
concentrations to which an individual has been exposed, i.e., DAC-hours;
or

(c) the assessment of dose equivalent by the use
of survey data.

(72) "Individual monitoring devices" or
"individual monitoring equipment" means devices designed to be worn
by a single individual for the assessment of dose equivalent such as film
badges, thermoluminescence dosimeters (TLDs), pocket ionization chambers, and
personal ("lapel") air sampling devices.

(73) "Inhalation class" (see "Class"
defined in this Rule).

(74) "Inspection" means an examination or
observation by the agency to determine compliance with rules, orders,
requirements and conditions of the agency or the Commission.

(75) "Internal dose" means that portion of the
dose equivalent received from radioactive material taken into the body.

(76) "Lens dose equivalent" (LDE) applies to
the external exposure of the lens of the eye and is taken as the dose
equivalent at a tissue depth of 0.3 cm (300 mg/cm2).

(78) "Licensee" means any person who is
licensed by the agency pursuant to Section .0300 of this Chapter.

(79) "Licensing state" means any state designated
as such by the Conference of Radiation Control Program Directors, Inc. Unless
the context indicates otherwise, use of the term Agreement State
in this Chapter includes licensing state with respect to naturally occurring
and accelerator produced radioactive material (NARM).

(81) "Loose-fitting facepiece" means a
respiratory inlet covering that is designed to form a partial seal with the
face.

(82) "Lost or missing licensed radioactive
material" means licensed radioactive material whose location is unknown. It
includes material that has been shipped but has not reached its destination and
whose location cannot be readily traced in the transportation system.

(83) "Low dose-rate remote afterloader" (LDR)
means a brachytherapy device that remotely delivers a dose rate of less than or
equal to 2 gray (200 rads) per hour at the point or surface where the dose is
prescribed.

(84) "Lung class" (see "Class" as
defined in this Rule).

(85) "Manual brachytherapy" means a type of
brachytherapy in which the brachytherapy seeds, ribbons) are manually placed
topically on or inserted either into the body cavities that are in close
proximity to a treatment site or directly into the tissue volume.

(86) "Medical event" means an event that meets
the criteria in Rule .0364 of this Chapter.

(87) "Medical use" means the intentional
internal or external administration of radioactive material or the radiation
therefrom to patients or human research subjects under the supervision of an
authorized user.

(88) "Medium dose-rate remote afterloader"
means a brachytherapy device that remotely delivers a dose rate of greater than
2 gray (200 rads), but less than 12 gray (1200 rads) per hour at the point or
surface where the dose is prescribed.

(89) "Member of the public" means any
individual except when that individual is receiving an occupational dose.

(92) "Monitoring," "radiation
monitoring" or "radiation protection monitoring" means the
measurement of radiation levels, concentrations, surface area concentrations or
quantities of radioactive material and the use of the results of these
measurements to evaluate potential exposures and doses.

(94) "Negative pressure respirator" means a
tight-fitting respirator in which the air pressure inside the facepiece is
negative during inhalation with respect to the ambient air pressure outside of
the respirator.

(95) "Nonstochastic effect" or "deterministic
effect" means health effects, the severity of which vary with the dose and
for which a threshold is believed to exist. Radiation-induced cataract
formation is an example of a nonstochastic effect.

(96) "NRC" means the United States Nuclear
Regulatory Commission or its authorized representatives.

(97) "Occupational dose" means the dose
received by an individual in the course of employment in which the individual's
assigned duties involve exposure to radiation or radioactive material from
licensed and unlicensed sources of radiation, whether in the possession of the
licensee or registrant or other person. Occupational dose does not include doses
received from background radiation, as a patient from medical practices, from
exposure to individuals administered radioactive material and released in
accordance with Rule .0358 of this Chapter, from voluntary participation in
medical research programs, or as a member of the public.

(98) "Particle accelerator" means any machine
capable of accelerating electrons, protons, deuterons, or other charged particles,
in a vacuum and of discharging the resultant particulate or other radiation
into a medium at energies usually in excess of one megaelectron volt. For
purposes of this definition, "accelerator" is an equivalent term.

(99) "Patient intervention" means actions by
the patient or human research subject, whether intentional or unintentional,
such as dislodging or removing treatment devices or prematurely terminating the
administration.

(100) "Person" has the meaning as defined in G.S.
104E-5(11).

(101) "Personnel monitoring equipment" means
devices, such as film badges, pocket dosimeters, and thermoluminescent
dosimeters, designed to be worn or carried by an individual for the purpose of
estimating the dose of radiation received by the individual.

(c) for gamma stereotactic radiosurgery, the
total dose as documented in the written directive; or

(d) for remote brachytherapy afterloaders, the
total dose and dose per fraction as documented in a written directive.

(110) "Pressure demand respirator" means a
positive pressure atmosphere-supplying respirator that admits breathing air to the
facepiece when the positive pressure is reduced inside the facepiece by
inhalation.

(111) "Public dose" means the dose received by a
member of the public from exposure to radiation or radioactive material
released by a licensee or registrant, or another source of radiation within a
licensee's or registrant's control. It does not include occupational dose or
doses received from background radiation, as a patient from medical practices,
from exposure to individuals administered radioactive material and released in
accordance with Rule .0358 of this Chapter, or from voluntary participation in
medical research programs.

(a) Is approximately one-tenth of the activity
of typical high dose-rate remote afterloader sources; and

(b) Is used to simulate the radiobiology of a
low dose-rate treatment by inserting the source for a given fraction of each
hour.

(113) "Qualitative fit test" (QLFT) means a
pass/fail fit test to assess the adequacy of respirator fit that relies on the individual's
response to the test agent.

(114) "Quality factor" (Q) means the modifying
factor that is used to derive dose equivalent from absorbed dose. Quality
factors are provided in the definition of rem in this Rule.

(115) "Quantitative fit test" (QNFT) means an
assessment of the adequacy of respirator fit by numerically measuring the
amount of leakage into the respirator.

(116) "Quarter" means a period of time equal to
one-fourth of the year observed by the licensee or registrant (approximately 13
consecutive weeks), providing that the beginning of the first quarter in a year
coincides with the starting date of the year and that no day is omitted or
duplicated in consecutive quarters.

(117) "Quarterly" means either:

(a) at intervals not to exceed 13 weeks; or

(b) once per 13 weeks at about the same time
during each 13 week period (completed during the same month of the quarter
(first month, second month or third month) each quarter over a time period of
several quarters.

(118) "Rad" is the special unit of absorbed dose.
One rad is equal to an absorbed dose of 100 ergs/gram or 0.01 joule/kilogram
(0.01 gray).

(119) "Radiation", except as otherwise defined in
Section .1400 of this Chapter, has the meaning as defined in G.S. 104E-5(12).

(120) "Radiation area" means an area, accessible
to individuals, in which radiation levels could result in an individual
receiving a dose equivalent in excess of 0.005 rem (0.05 mSv) in one hour at 30
centimeters from the radiation source or from any surface that the radiation
penetrates.

(121) "Radiation dose" means dose.

(122) "Radiation machine" has the meaning as
defined in G.S. 104E-5(13).

(123) "Radiation safety officer" means one who has
the knowledge and responsibility to apply appropriate radiation protection
rules.

(124) "Radioactive material" has the meaning as
defined in G.S. 104E-5(14).

(125) "Radioactive waste disposal facility" means
any low-level radioactive waste disposal facility, as defined in G.S. 104E-5(9c),
established for the purpose of receiving low-level radioactive waste, as
defined in Rule .1202 of this Chapter, generated by another licensee for the
purpose of disposal.

(126) "Radioactive waste processing facility"
means any low-level radioactive waste facility, as defined in G.S. 104E-5(9b),
established for the purpose of receiving waste, as defined in this Rule,
generated by another licensee to be stored, compacted, incinerated or treated.

(127) "Radioactivity" means the disintegration of
unstable atomic nuclei by emission of radiation.

(128) "Radiobioassay" means bioassay.

(129) "Reference man" means a hypothetical
aggregation of human physical and physiological characteristics arrived at by
international consensus as published by the International Commission on
Radiological Protection. These characteristics may be used by researchers and
public health workers to standardize results of experiments and to relate
biological insult to a common base.

(130) "Registrant" means any person who is
registered with the agency as required by provisions of these Rules or the Act.

(131) "Registration" means registration with the
agency in accordance with these Rules.

(132) "Regulations of the U.S. Department of
Transportation" means the regulations in 49 CFR Parts 100-189.

(133) "Rem" is the special unit of any of the
quantities expressed as dose equivalent. The dose equivalent in rems is equal
to the absorbed dose in rads multiplied by the quality factor (1 rem = 0.01
sievert). As used in this Chapter, the quality factors for converting absorbed
dose to dose equivalent are as follows:

QUALITY FACTORS AND
ABSORBED DOSE EQUIVALENCIES

TYPE OF RADIATION Quality
Factor Absorbed

(Q) Dose
Equal

to a Unit

Dose Equivalenta

X-, gamma, or beta radiation 1 1

Alpha particles, multiple-charged

particles, fission fragments

and heavy particles of unknown

charge 20 0.05

Neutrons of unknown energy 10 0.1

High-energy protons 10 0.1

a Absorbed dose in rad equal to one rem or the
absorbed dose in gray equal to one sievert.

If it is more convenient to measure the neutron fluence rate
than to determine the neutron dose equivalent rate in rems per hour or sieverts
per hour, one rem (0.01 Sv) of neutron radiation of unknown energies may, for
purposes of the rules of this Chapter, be assumed to result from a total
fluence of 25 million neutrons per square centimeter incident upon the body.

If sufficient information exists to estimate the approximate
energy distribution of the neutrons, the licensee or registrant may use the
fluence rate per unit dose equivalent or the appropriate Q value from the
following table to convert a measured tissue dose in rads to dose equivalent in
rems:

MEAN QUALITY FACTORS,
Q, AND FLUENCE PER UNIT DOSE

EQUIVALENT FOR
MONOENERGETIC NEUTRONS

Neutron Quality Fluence
per Unit

Energy Factora Dose
Equivalentb

(MeV) (Q) (neutrons
cm-2 rem-1)

(thermal) 2.5 x 10-8 2 980
x 106

1 x 10-7 2 980
x 106

1 x 10-6 2 810
x 106

1 x 10-5 2 810
x 106

1 x 10-4 2 840
x 106

1 x 10-3 2 980
x 106

1 x 10-2 2.5 1010
x 106

1 x 10-1 7.5 170
x 106

5 x 10-1 11 39
x 106

1 11 27
x 106

2.5 9 29
x 106

5 8 23
x 106

7 7 24
x 106

10 6.5 24
x 106

14 7.5 17
x 106

20 8 16
x 106

40 7 14
x 106

60 5.5 16
x 106

1 x 102 4 20
x 106

2 x 102 3.5 19
x 106

3 x 102 3.5 16
x 106

4 x 102 3.5 14
x 106

a Value of quality factor (Q) at the point where
the dose equivalent is maximum in a 30-cm diameter cylinder tissue-equivalent
phantom.

(b) the extension of investigative findings and
theories of a scientific or technical nature into practical application for
experimental and demonstration purposes, including the experimental production
and testing of models, devices, equipment, materials, and processes.

Research and development does not include
the internal or external administration of radiation or radioactive material to
human beings.

(135) "Residual radioactivity" means radioactivity
in structures, materials, soils, groundwater, and other media at a site
resulting from activities under the licensee's control. This includes radioactivity
from all licensed and unlicensed sources used by the licensee, but excludes
background radiation. It also includes radioactive materials remaining at the
site as a result of routine or accidental releases of radioactive material at
the site and previous burials of radioactive materials at the site, even if the
burials were made in accordance with the provisions of Section .1600 of this
Chapter.

(136) "Respiratory protective device" means an
apparatus, such as a respirator, used to reduce the individual's intake of
airborne radioactive materials.

(137) "Restricted area" means an area, access to
which is controlled by the licensee or registrant for purposes of protecting
individuals against undue risks from exposure to radiation and radioactive
materials. Restricted area does not include areas used as residential
quarters, but separate rooms in a residential building may be set apart as a
restricted area.

(139) "Sanitary sewerage" means a system of public
sewers for carrying off waste water and refuse, but excluding sewage treatment
facilities, septic tanks, and leach fields owned or operated by the licensee.

(140) "Sealed source" means radioactive material
that is encased in a capsule designed to prevent leakage or escape of the
radioactive material.

(141) "Sealed source and device registry" means
the national registry that contains all the registration certificates,
generated by both NRC and the Agreement States, that summarize the radiation
safety information for the sealed sources and devices and describe the
licensing and use conditions approved for the product.

(142) "Self-contained breathing apparatus (SCBA)"
means an atmosphere-supplying respirator for which the breathing air source is
designed to be carried by the user.

(143) "Semiannually" means either:

(a) at intervals not to exceed six months; or

(b) once per six months at about the same time
during each six month period (completed during the sixth month of each six
month period over multiple six month periods).

(144) "Shallow-dose equivalent" (Hs), which applies to the external
exposure of the skin of the whole body or the skin of an extremity, is taken as
the dose equivalent at a tissue depth of 0.007 centimeter (7 mg/cm2).

(145) "SI unit" means a unit of measure from the
International System of Units as established by the General Conference of
Weights and Measures.

(146) "Sievert" is the SI unit of any of the
quantities expressed as dose equivalent. The dose equivalent in sieverts is
equal to the absorbed dose in grays multiplied by the quality factor (1 Sv =
100 rems).

(147) "Site boundary" means that line beyond which
the land or property is not owned, leased, or otherwise controlled by the
licensee or registrant.

(148) "Source material" has the meaning as defined
in G.S. 104E-5(15).

(149) "Source of radiation" means any radioactive
material, or any device or equipment emitting or capable of producing
radiation.

(150) "Special form radioactive material" means
radioactive material which satisfies the following conditions:

(a) It is either a single solid piece or is
contained in a sealed capsule that can be opened only by destroying the
capsule;

(b) The piece or capsule has at least one
dimension not less than five millimeters (0.197 inch); and

(c) It satisfies the test requirements specified
by the U.S. Nuclear Regulatory Commission, Subpart F of 10 CFR Part 71, and the
tests prescribed in Rule .0114 of this Section. A special form encapsulation
designed in accordance with the U.S. Nuclear Regulatory Commission
requirements, Subpart F of 10 CFR Part 71, in effect on June 30, 1984, and
constructed prior to July 1, 1985, may continue to be used. A special form
encapsulation either designed or constructed after June 30, 1985, must meet
requirements of this definition applicable at the time of its design or
construction.

(151) "Special nuclear material" has the meaning
as defined in G.S. 104E-5(16).

(152) "Special nuclear material in quantities not
sufficient to form a critical mass" means uranium enriched in the isotope
uranium-235 in quantities not exceeding 350 grams of contained uranium-235;
uranium-233 in quantities not exceeding 200 grams; plutonium in quantities not
exceeding 200 grams; or any combination of uranium-235, uranium enriched in
uranium-235 and plutonium in accordance with the following formula: For each
kind of special nuclear material, determine the ratio between the quantity of
that special nuclear material and the quantity specified in this Rule for the
same kind of special nuclear material. The sum of these ratios for all the
kinds of special nuclear material in combination shall not exceed one. For
example, the following quantities in combination would not exceed the
limitations and are within the formula, as follows:

(154) "Stereotactic radiosurgery" means the use of
external radiation in conjunction with a stereotactic guidance device to
precisely deliver a therapeutic dose to a tissue volume.

(155) "Stochastic effects" means health effects
that occur randomly and for which the probability of the effect occurring,
rather than its severity, is assumed to be a linear function of dose without
threshold. Hereditary effects and cancer incidence are examples of stochastic
effects.

(156) "Supplied-air respirator" (SAR) or "airline
respirator" means an atmosphere-supplying respirator for which the source
of breathing air is not designed to be carried by the user.

(157) "Survey" means an evaluation of the
radiological conditions and potential hazards incident to the production, use,
transfer, release, disposal, or presence of sources of radiation. When
appropriate, such an evaluation includes a physical survey of the location of
sources of radiation and measurements or calculations of levels of radiation,
or concentrations or quantities of radioactive material present.

(158) "Therapeutic dosage" means a dosage of
unsealed radioactive material that is intended to deliver a radiation dose to a
patient or human research subject for palliative or curative treatment.

(159) "These Rules" means Chapter 11 of this
Title.

(160) "Tight-fitting facepiece" means a
respiratory inlet covering that forms a complete seal with the face.

(161) "To the extent practicable" means to the
extent feasible or capable of being done or carried out with reasonable effort,
taking into account the state of technology, the economics of improvements in
relation to benefits to the public health and safety, and other societal and
socioeconomic considerations.

(163) "Toxic or hazardous constituent of the
waste" means the nonradioactive content of waste which, notwithstanding
the radioactive content, would be classified as "hazardous waste" as
defined in G.S. 130A-290(8).

(164) "Treatment site" means the anatomical
description of the tissue intended to receive a radiation dose, as described in
a written directive.

(165) "Type A quantity" means a quantity of
radioactive material, the aggregate radioactivity of which does not exceed A1
for special form radioactive material or A2 for normal form
radioactive material, where A1 and A2 are given in Rule
.0113 of this Section or may be determined by procedures described in that
Rule. All quantities of radioactive material greater than a Type A quantity
are Type B.

(166) "Unit dosage" means a dosage intended for
medical use in an individual that has been obtained from a manufacturer or
preparer licensed pursuant to 10 CFR 32.72 or equivalent agreement state
requirements.

(167) "Unrefined and unprocessed ore" means ore in
its natural form prior to any processing, such as grinding, roasting,
beneficiating, or refining.

(168) "Unrestricted area" means an area, access to
which is neither limited nor controlled by the licensee or registrant.

(170) "Very high radiation area" means an area,
accessible to individuals, in which radiation levels from sources external to
the body could result in an individual receiving an absorbed dose in excess of
500 rads (5 grays) in one hour at one meter from a radiation source or from any
surface that the radiation penetrates. At very high doses received at high
dose rates, units of absorbed dose (e.g., rads and grays) are
appropriate, rather than units of dose equivalent (e.g., rems and
sieverts).

(171) "Waste" means low-level radioactive waste as
defined in G.S. 104E-5(9a) and includes those low-level radioactive wastes
containing source, special nuclear, or radioactive material that are acceptable
for disposal in a land disposal facility. For purposes of this definition,
low-level waste means radioactive waste not classified as high-level
radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material
as defined in this Rule, and licensed naturally occurring and accelerator
produced radioactive material which is not subject to regulation by the U.S.
Nuclear Regulatory Commission under the Atomic Energy Act of 1954, as amended,
except as defined differently in Rule .1202 of this Chapter.

(172) "Week" means seven consecutive days.

(173) "Weighting factor", wT, for an organ or tissue (T) is the proportion of
the risk of stochastic effects resulting from irradiation of that organ or
tissue to the total risk of stochastic effects when the whole body is irradiated
uniformly. For calculating the effective dose equivalent, the values of wT are:

ORGAN DOSE WEIGHTING
FACTORS

Organ or

Tissue wT

Gonads 0.25

Breast 0.15

Red bone marrow 0.12

Lung 0.12

Thyroid 0.03

Bone surfaces 0.03

Remainder 0.30a

Whole body 1.00b

a 0.30 results from 0.06 for each of 5
"remainder" organs (excluding the skin and the lens of the eye) that
receive the highest doses.

b For the purpose of weighting the external whole
body dose (for adding it to the internal dose), a single weighting factor, wT = 1.0, has been specified.

(175) "Worker" means an individual engaged in work
under a license or registration issued by the agency and controlled by a
licensee or registrant, but does not include the licensee or registrant.

(176) "Working level" (WL) is any combination of
short-lived radon daughters (for radon-222: polonium-218, lead-214,
bismuth-214, and polonium-214; and for radon-220: polonium-216, lead-212,
bismuth-212, and polonium-212) in one liter of air that will result in the ultimate
emission of 1.3 x 105 MeV of potential alpha particle energy.

(177) "Working level month" (WLM) means an
exposure to one working level for 170 hours.

(178) "Written directive" means an order in
writing for a specific patient or human research subject dated and signed by an
authorized user prior to the administration of a radiopharmaceutical or
radiation from a licensed source, except as specified in Sub-item (e) of this
definition, containing the patient or human research subject's name and the
following information:

(a) for the administration of greater than 30
microcuries (1.11 Megabecquerels (MBq)) of sodium iodide I-131, the dosage;

(b) for the therapeutic administration of a
radiopharmaceutical other than sodium iodide I-131:

(i) radionuclide;

(ii) dosage; and

(iii) route of administration;

(c) for teletherapy or accelerator radiation
therapy:

(i) total dose;

(ii) dose per fraction;

(iii) treatment site; and

(iv) number of fractions;

(d) for high-dose-rate remote afterloading
brachytherapy:

(i) radionuclide;

(ii) treatment site;

(iii) dose per fraction

(iv) number of fractions; and

(v) total dose;

(e) for all other brachytherapy:

(i) prior to implantation:

(A) radionuclide;

(B) treatment site; and

(C) dose; and

(ii) after implantation:

(A) radionuclide;

(B) treatment site;

(C) number of sources;

(D) total source strength and exposure time; and

(E) total dose; and

(f) for gamma stereotactic radiosurgery:

(i) the total dose;

(ii) treatment site; and

(iii) values for the target coordinate settings
per treatment for each anatomically distinct treatment site.

(179) "Year" means the period of time beginning in
January used to determine compliance with the provisions of Section .1600 of
this Chapter. The licensee or registrant may change the starting date of the
year used to determine compliance by the licensee or registrant provided that
the change is made at the beginning of the year and that no day is omitted or
duplicated in consecutive years.

Definitions of certain other words and phrases as used in
these Rules are set forth in Sections .0300, .0500, .0600, .0800, .1200, .1300,
.1400, and .1500 of this Chapter. Waste class is defined in Rule .1650 of this
Chapter.

(a) The agency may, upon application therefore, grant
individual exemptions or exceptions from the requirements of these Rules if it
will not result in radiation dose or contamination in excess of the limits
prescribed in these Rules for the protection of public health, safety or
property.

(b) Except as otherwise provided in this Rule, common and
contract or other carriers, freight forwarders, and warehousemen, who are
subject to the regulations of the U.S. Postal Service (39 CFR Parts 14 and 15),
are exempt from these Rules to the extent that they transport or store sources
of radiation in the regular course of their carriage for another or storage
incident thereto. Common, contract, or other carriers who are not exempt pursuant
to this Rule are subject to the provisions of Rule .0316 of this Chapter.
Notwithstanding these exemptions, common, contract or other carriers are
required to comply with the provisions of Rule .0316(c) of this Chapter to the
extent that these carriers are transporting spent nuclear fuel, as defined in
Rule .0316(c) of this Chapter, upon the highways of North Carolina.

(c) Any U.S. Department of Energy contractor or
subcontractor and any U.S. Nuclear Regulatory Commission contractor or
subcontractor of the following categories operating within this state is exempt
from these Rules to the extent that the contractor or subcontractor under his
contract receives, possesses, uses, transfers or acquires sources of radiation:

(1) prime contractors performing work for the
U.S. Department of Energy at U.S. government‑owned or controlled sites,
including the transportation of sources of radiation to or from such sites and
the performance of contract services during temporary interruptions of such
transportation;

(2) prime contractors of the U.S. Department of
Energy performing research in, or development, manufacture, storage, testing or
transportation of, atomic weapons or components thereof;

(3) prime contractors of the U.S. Department of
Energy using or operating nuclear reactors or other nuclear devices in a United
States government‑owned vehicle or vessel; and

(4) any other prime contractor or subcontractor
of the U.S. Department of Energy or of the U.S. Nuclear Regulatory Commission
when the agency and the U.S. Nuclear Regulatory Commission jointly determine
that:

(A) the exemption of the prime contractor or
subcontractor in Subparagraph (c)(4) of this Rule is authorized by law, and

(B) that under the terms of the contract or subcontract,
there is adequate assurance that the work thereunder can be accomplished
without undue risk to the public health and safety.

(a) The agency may, by license condition, registration
condition, or order, when not in conflict with any law, waive any requirement
in these Rules or impose additional requirements in accordance with 46 FR 7540 as
it deems appropriate or necessary to minimize danger to public health, safety
or property. Such additional requirements are subject to appeal procedures
contained in Section 15A NCAC 1B .0200.

(b) The Commission may by rule require radioactive material
licensees to procure and file with the department such bond, insurance or other
security as the Commission deems necessary to protect the state from costs for
emergency response and perpetual maintenance.

(a) Except as provided in Paragraph (b) of this Rule, all
communications and reports concerning these Rules and applications filed thereunder
shall be mailed to the agency at Radiation Protection Section, 1645 Mail
Service Center, Raleigh, North Carolina 27699-1600 or delivered to the agency
at its office located at 5505 Creedmoor Road, Suite 100, Raleigh, North
Carolina 27612.

(b) Except as specifically instructed otherwise by the
agency, immediate telephone notification and reports required by the rules in
this Chapter shall be directed to (919) 814-2250 from 8:00 a.m. to 5:30 p.m. on
business days.

(a) When an employee of the agency is qualified and is
specifically designated by the agency, the employee shall be an authorized
representative of the agency to conduct inspections, or tests, or surveys.

(b) When a public employee of other than the agency is
determined by the agency to be qualified, the agency may designate the employee
as an authorized representative of the agency to conduct specified inspections,
or tests, or surveys.

For a single radionuclide of known identity, the values of
A1 and A2 used for determining Type A quantity in the rules of this Chapter are
taken from Appendix A of 10 CFR 71 as revised at 48 Federal Register 35600,
August 5, 1983, and corrections at 48 Federal Register 38449, August 24, 1983.

Special form radioactive material as defined in Rule .0104
of this Section must satisfactorily pass the following tests:

(1) a free drop through a distance of 30 feet onto a
flat essentially unyielding horizontal surface, striking the surface in such a
position as to suffer maximum damage;

(2) impact of the flat circular end of a one‑inch
diameter steel rod weighing three pounds, dropped through a distance on a sheet
of lead, of hardness number 3.5 to 4.5 on the Vickers scale, and not more than
one inch thick supported by a smooth essentially unyielding surface;

(3) heating in air to a temperature of 1,475 F.
and remaining at that temperature for a period of ten minutes;

(4) immersion for 24 hours in water at room temperature
at pH 6 to pH 8, with a maximum conductivity of ten micromhos per centimeter.

Each licensee and registrant shall perform upon instructions
from the agency, or shall permit the agency to perform, such reasonable tests
as the agency deems appropriate or necessary including, but not limited to,
tests of:

(1) sources of radiation;

(2) facilities wherein sources of radiation are used or
stored;

(3) radiation detection and monitoring instruments; and

(4) other equipment and devices used in connection with
utilization or storage of licensed or registered sources of radiation.

(8) "Agreement Between the United States
Atomic Energy Commission and the State of North Carolina for Discontinuance of
Certain Commission Regulatory Authority and Responsibility within the State
Pursuant to Section 274 of the Atomic Energy Act of 1954, as Amended," signed
July 21, 1964;

(9) "Standards and Specifications for
Geodetic Control Networks" (September 1984);

(13) American National Standard N43.9 "Radiological
Safety for the Design and Construction of Apparatus for Gamma
Radiography".

(b) The rules, standards and other requirements
incorporated by reference in Paragraph (a) of this Rule are available for
inspection at the Agency at the address listed in Rule .0111 of this Section. Except
as noted in the Subparagraphs of this Paragraph, copies of the rules, standards
and other requirements incorporated by reference in Paragraph (a) of this Rule
may be obtained from the Superintendent of Documents, U.S. Government Printing
Office, Washington, D.C. 20402 at a cost as follows:

(1) Three dollars ($3.00) for the appendixes
listed in Subparagraph (a)(1) of this Rule, available from the Agency;

(2) Sixty-Seven dollars ($67.00) for the
regulations listed in Subparagraph (a)(2) of this Rule in a volume containing
10 CFR Parts 1-50;

(3) Sixty-Four dollars ($64.00) for the
regulations listed in Subparagraph (a)(3) of this Rule in a volume containing
10 CFR Parts 51-199;

(4) Sixty-Six dollars ($66.00) for the
regulations listed in Subparagraph (a)(4) of this Rule in a volume containing
21 CFR Parts 800-1299;

(5) Forty-Seven dollars ($47.00) for the
regulations listed in Subparagraph (a)(5) of this Rule in a volume containing 39
CFR;

(6) Thirty-six dollars ($36.00) for the manual
listed in Subparagraph (a)(6) of this Rule;
http://pe.usps.gov/text/dmm300/dmm300_landing.htm;

(7) Fifty-Six dollars ($56.00) for the
regulations listed in Subparagraph (a)(7) of this Rule in a volume containing
40 CFR Parts 260-299;

(9) One dollar ($1.00) for the agreement in
Subparagraph (a)(9) of this Rule, available from the Agency;

(10) Two dollars and eighty-five cents ($2.85)
for the standards and specifications in Subparagraph (a)(10) of this Rule,
available from the National Geodetic Information Center, N/CG174, Rockwall
Building, Room 24, National Geodetic Survey, NOAA, Rockville, MD 20852;

(11) Two dollars and eighty-five cents ($2.85)
for the standards and specifications in Subparagraph (a)(11) of this Rule,
available from the National Geodetic Information Center, NCG174, Rockwall
Building, Room 24, National Geodetic Survey, NOAA, Rockville, MD 20852;

(13) Two dollars ($2.00) for the document in
Subparagraph (a)(13) of this Rule, available from the Agency; and

(14) Twenty-Five dollars plus five dollars
shipping and handling ($30.00) for the American National Standard N43.9 in
Subparagraph (a)(14) of this Rule, available from the American National
Standards Institute, Inc., 1430 Broadway, New York, New York 10018, telephone
number (212) 642-4900.

(15) The Code of Federal Regulations is available
free of charge on the internet at
http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR.

(c) Nothing in this incorporation by reference of 10 CFR
Part 61 in Subparagraph (a)(3) of this Rule shall limit or affect the continued
applicability of G.S. 104E-25(a) and (b).

Any licensee or registrant may choose to imple­ment the
rules in Section .1600 of this Chapter prior to the January 1, 1994 effective
date of that Section, in lieu of the rules in Section .0400 of this Chapter,
provided such licensee or registrant shall:

(1) implement all rules in Section .1600 of
this Chapter, except as exempted by the provisions of Rule .1602(c) of this
Chap­ter;

(2) comply with the rules in Section .1600 of
this Chapter in lieu of any rule in Section .0400 of this Chapter that is cited
in license or registration conditions, except as otherwise provided in Rule
.1602 of this Chapter; and

(3) provide written notification of implemen­tation
to the agency at the address in Rule .0111 of this Section.

(a) This Section provides for the registration of radiation
machines, radiation machine facilities and persons who provide other
radiological services.

(b) For purposes of this Section, "facility"
means the location at which one or more radiation machines are installed or
located within one building, vehicle, or under one roof and are under the same
administrative control.

(c) In addition to the requirements of this Section, all
registrants are subject to the provisions of the other sections of this
Chapter.

(d) Special requirements for registration of particle
accelerators are provided in Section .0900 of this Chapter and are in addition
to the requirements of this Section.

(e) In addition to the requirements of this Section, all
registrants are subject to the annual fee provisions contained in Section .1100
of this Chapter.

(a) Electronic equipment that produces radiation incidental
to its operation for other purposes is exempt from the registration and
notification requirements of this Section provided that the dose equivalent
rate average over an area of ten square centimeters does not exceed 0.5 mrem
per hour at five centimeters from any accessible surface of the equipment when
any external shielding is removed. The production, testing, or factory
servicing of such equipment are not exempt.

(b) Radiation machines while in transit or storage incident
thereto are exempt from the requirements of this Section.

(c) Domestic television receivers are exempt from the
requirements of this Section.

(a) Each person having an unregistered radiation machine or
facility shall:

(1) apply for registration of such facility and
each radiation machine within 30 days following initial operation of that
facility and each radiation machine. Application for registration shall be
completed on agency forms and shall contain all information required by the
forms and accompanying instructions. The registration of the first radiation machine
at a facility constitutes registration of the facility itself.

(2) designate on the application form an
individual who shall be responsible for radiation protection.

(b) Agency forms described in Subparagraph (a)(1) of this
Rule require the following and other information:

(1) name, address and telephone number of the
radiation machine facility;

(2) name of the person responsible for
radiation protection in the facility;

(3) name, training and experience of the person
designated in Subparagraph (a)(2) of this Rule;

(4) the manufacturer, model number, serial
number and type of each radiation machine located within the facility;

(5) the date of the application and the
signatures of the persons specified in Subparagraphs (b)(2) and (3) of this
Rule.

(a) Except as provided in Paragraph (b) of this Rule or
otherwise authorized in writing by the agency, each person registered pursuant
to Rule .0203 of this Section shall prohibit any person from furnishing
equipment services described in Rule .0205(d) of this Section to his facility
until such person provides evidence that he is currently registered with the
agency as a provider of such services in accordance with Rule .0205 of this
Section.

(b) No person registered pursuant to the provisions of Rule
.0203 of this Section shall perform any services listed in Rule .0205(d) of
this Section in his facility unless such person satisfies the applicable
requirements in Rules .0205, .0213, and .0214 of this Section and has received
written authorization from the agency to perform such services.

(a) Each person who is engaged in the business of
installing or offering to install radiation machines and machine components or
is engaged in the business of furnishing or offering to furnish any equipment
services listed in Paragraph (d) of this Rule in this state, to any agency
licensee or registrant, shall apply for registration of such services with the
agency prior to furnishing or offering to furnish any of these services.

(b) Application for registration shall be completed on
appropriate form(s) provided by the agency and shall contain all information
required by the agency as indicated on the form and accompanying instructions.
This information shall include:

(1) the name, address and telephone number of:

(A) the individual or the company to be registered;

(B) the owner(s) of the company;

(2) the description of the services to be
provided;

(3) the name, training and experience of each
person who provides services specified in Paragraph (d) of this Rule;

(4) the date of the application and the
signature of the person responsible for the company; and

(5) any additional information the agency
determines to be necessary for evaluation of the application for registration.

(c) Each person applying for registration under Paragraph
(a) of this Rule shall certify that he has read and understands the
requirements of the rules in this Chapter.

(d) For the purpose of this Section, equipment services
include:

(1) direct sale and transfer of radiation
machines and machine components to end users;

(a) Persons, registered pursuant to Rule .0205 of this
Section, who sell, lease, transfer, lend, dispose of, assemble or install
radiation machines in this state shall, within 30 days after each calendar
quarter, notify the agency at the address in Rule .0111 of this Chapter, of:

(1) whether any radiation machines were
installed, transferred, or disposed of during the calendar quarter;

(2) the name and address of persons who
received radiation machines during the calendar quarter;

(3) the manufacturer, model and serial number
of each radiation machine transferred or disposed of;

(4) the date of transfer of each radiation
machine.

(b) The information specified in Subparagraphs (a)(2), (3)
and (4) of this Rule may be omitted from the quarterly reports required in (a)
of this Rule for any diagnostic x‑ray system which contains certified
components when a copy of the assembler's report prepared in compliance with 21
CFR 1020.30(d) is submitted to the agency.

(a) The agency shall issue a notice of registration upon a
determination that an applicant:

(1) is qualified by reason of education,
training or experience in the use and hazards of radiation sources described in
the application for registration;

(2) has facilities and equipment which meet the
requirements in these Rules;

(3) has established a radiation protection
program, appropriate to the registered activities, which assures compliance
with radiation protection requirements in these Rules; and

(4) meets the applicable requirements in this
Chapter.

(b) The agency may, by registration condition or order,
when not in conflict with any law, waive any requirement in these Rules or
impose requirements with respect to the registrant's receipt, possession, use
and transfer of radiation machines as the agency deems appropriate or necessary
for compliance with the rules in this Chapter. Such additional requirements
are subject to appeal under 15A NCAC 1B .0200.

(c) The agency may refuse to grant a registration required
in Rules .0203 and .0205 of this Section to any applicant who does not possess
adequate qualifications or equipment or satisfy the applicable requirements in
this Chapter; provided that, before any order is entered denying an application
for registration, the agency shall give notice and grant a hearing as provided
in G.S. 150B.

(a) Persons registered pursuant to Rule .0203 of this
Section shall notify the agency in writing prior to transfer of a registered
radiation machine to another person required to be registered pursuant to Rule
.0203(a) of this Section. This Rule does not prohibit transfer without prior
notification to sales and service companies registered pursuant to Rule .0205
of this Section.

(b) The notification shall include:

(1) the name and address of the transferee, and

(2) the manufacturer, model number and serial
number of the radiation machine to be transferred.

(a) No person registered pursuant to Rule .0205 of this
Section for x‑ray sales or installations shall make, sell, lease,
transfer, lend, assemble, or install radiation machines or equipment used in connection
with such machines unless such machines and equipment when placed in operation
shall meet the applicable requirements of these Rules.

(b) No person, in any advertisement, shall refer to the
fact that he or his facility is registered with the agency pursuant to the
provisions of Rule .0203 or .0205 of this Section and no person shall state or
imply that any activity under such registration has been approved by the
agency.

(c) No person registered pursuant to Rule .0205 of this
Section shall install radiation machines which are subject to provisions of
Section .0600 of this Chapter unless the registrant first determines that the
agency has issued written acknowledgement of receipt of any facility and
shielding design required in Rule .0603 of this Chapter.

(a) No person shall bring any radiation machine into the
state, for any temporary use, unless such person has given a written notice to
the agency at least five working days before the machine is to be used in the
state. The notice shall include the type of radiation machine; the nature,
duration, and scope of use; and the exact location(s) where the radiation
machine is to be used. If, for a specific case, the five working day period
would impose an undue hardship on the person, he may, upon application to the
agency, obtain permission to proceed sooner.

(b) The person in Paragraph (a) of this Rule shall:

(1) comply with all applicable rules in this
Chapter, including registration pursuant to Rule .0203 of this Section; and

(2) supply the agency with such other
information as the agency may reasonably request.

(a) The terms and conditions of all registrations are
subject to amendment, revision or modification and all registrations are
subject to suspension or revocation by reason of:

(1) rules adopted pursuant to provisions of the
Act; or

(2) orders issued by the agency pursuant to
provisions of the Act and rules adopted pursuant to provisions of the Act.

(b) Any registration may be revoked, suspended or modified
in whole or in part:

(1) for any material false statement in the
application or in any statement of fact required by provisions of this Section;

(2) because of conditions which would warrant
the agency to refuse to grant a registration on original application revealed
by:

(A) the application;

(B) any statement of fact;

(C) any report, record, inspection or other means; or

(3) for violations of, or failure to observe
any of the terms and conditions of the Act, the registration, the rules of this
Chapter, or order of the agency.

(c) Except in cases of willfulness or those in which the
public health, interest or safety requires otherwise, prior to the institution
of proceedings for modification, revocation or suspension of a registrant, the
agency shall:

(1) call to the attention of the registrant in
writing the facts or conduct which may warrant these actions, and

(2) provide an opportunity for the registrant
to demonstrate or achieve compliance with all lawful requirements.

(d) Before any order is entered suspending, revoking or modifying
a registration, the agency shall give notice and grant a hearing as provided in
Chapter 150B of the North Carolina General Statutes.

(e) The agency may terminate a registration upon written
request submitted by the registrant to the agency.

(a) An applicant for registration of diagnostic area
radiation survey, diagnostic radiation output measurements or therapeutic
calibration services pursuant to Rule .0205 of this Section shall meet the
following additional requirements:

(1) The applicant shall have adequate radiation
survey and radiation measurement equipment appropriate to the services
requested for authorization.

(2) The applicant shall ensure that the
equipment in Subparagraph (a)(1) of this Rule is calibrated at least every 12
months by persons registered to provide such services pursuant to Rule .0205 of
this Section, except as provided in Subparagraph (a)(3) of this Rule. The
agency may approve less frequent calibration of equipment used for therapy
calibration, provided the applicant satisfies the agency that the proposed
frequency and procedures will provide equivalent or better assurance of proper
calibration.

(3) The applicant may perform the equipment
calibrations required in Subparagraph (a)(2) of this Rule provided that:

(A) such calibrations are currently traceable to the
National Institute of Standards and Technology;

(B) the calibration procedures are approved by the
agency;

(C) the radiation sources used for such calibration are
licensed or registered as required by the rules in this Chapter; and

(D) the equipment is labeled to indicate the date of
calibration and records of the calibration are maintained.

(4) The applicant shall submit:

(A) a description of the procedures that will be used in
performing area radiation surveys including a list of all guides and references
to the employed;

(B) a copy of all forms, reports and documents that will
be supplied to customers;

(C) samples of three different types of surveys;

(D) samples of three reports of diagnostic radiation
output measurements; and

(E) samples of three therapeutic calibration reports.

(b) An applicant for registration of services pursuant to
Rule .0205 of this Section who proposes to provide diagnostic radiographic,
fluoroscopic and therapeutic facility and shielding design services shall meet
the following additional requirements:

(1) The applicant shall submit examples of the
facility and shielding design which will be provided to clients.

(2) The applicant shall submit examples of the
calculations which will be performed as part of the facility and shielding
design along with any guides, occupancy factor rationales, and workload
estimation rationales which will be used.

(3) The applicant shall ensure that the
facility and shielding design services provided to licensees and registrants of
the agency satisfy the applicable requirements in this Chapter.

(a) Each person registered pursuant to Rule .0205 of this
Section shall be qualified by reason of education, training and experience to
provide the services for which registration is requested. The following are
minimum qualifications for specific types of services:

(1) Class I ‑ sales of radiation machines
and machine components to end users: The applicant must certify knowledge of
familiarity with the rules which govern the possession, installation and use of
radiation machines in North Carolina.

(2) Class II ‑ installation and service
of radiation machines and machine components including the making of diagnostic
radiation output measurements to verify performance associated with the
installation or service:

(A) manufacturer's equipment school for service,
maintenance and installation for the type of machine use (e.g. dental
intraoral, medical diagnostic or medical fluoroscopic) or equivalent training;

(B) training in principles of radiation protection; and

(C) three months of experience in installation and
service of radiation machines and machine components.

(A) certification by the American Board of Radiology in
therapeutic radiological physics, radiological physics, roentgen‑ray and
gamma ray physics, or x‑ray and radium physics; or certification by the
American Board of Medical Physics; or

(8) Class VIII ‑ personnel dosimetry
service: The applicant must hold current personnel dosimetry accreditation
from the National Voluntary Laboratory Accreditation Program (NVLAP) of the
National Institute of Standards and Technology or use NVLAP accredited
dosimetry.

(A) baccalaureate degree in a physical science (e.g.
physics, chemistry or radiologic science), engineering or related field and two
years of progressive experience in medical or health physics; graduate training
in medical or health physics may be substituted on a year for year basis; or

(B) certification by the American Board of Radiology in
therapeutic radiological physics, radiological physics, roentgen‑ray and
gamma ray physics, or x‑ray and radium physics; certification by the
American Board of Health Physics in health physics or certification by the
American Board of Medical Physics.

(b) Any person not meeting the requirements in Paragraph
(a) of this Rule may apply to the agency for registration, provided such person
demonstrates education, training and experience which is equivalent to that
required in Paragraph (a) of this Rule.

(c) Any person registered prior to the effective date of
this Rule to provide equipment services pursuant to Rule .0205 of this Section
shall meet the education, training and experience requirements in Paragraph (a)
or (b) of this Rule no later than 24 months after the effective date of this
Rule.

(d) The agency shall initiate action to terminate the
registration of any person who fails to comply with the requirements of
Paragraph (c) of this Rule.

(a) This Section provides for the licensing of radioactive
material. No person shall receive, possess, use, transfer, own, transport,
manufacture and produce, or acquire radioactive material except as authorized
in a specific or general license issued pursuant to, or as otherwise provided
in, this Section.

(b) In addition to the requirements of this Section:

(1) All licensees are subject to the
requirements of Sections .1000, .1100 and .1600 of this Chapter, except as
otherwise provided in the rules of this Section;

(2) Licensees engaged in industrial
radiographic operations are subject to the requirements of Section .0500 of
this Chapter;

(3) Licensees using sealed sources in the
healing arts are subject to the requirements of Section .0700 of this Chapter;

(4) Licensees engaged in the operation of
radioactive waste disposal facilities are subject to the requirements of
Section .1200 of this Chapter; and

(5) Licensees engaged in well-logging
operations are subject to the requirements of Section .1300 of this Chapter.

(c) The rules in this Section do not apply to persons
licensed pursuant to the rules in Section .1200 of this Chapter except as
specifically provided otherwise in Section .1200.

History Note: Authority G.S. 104E-7; 104E-9(8);
104E-10(b);

Eff. February 1, 1980;

Amended Eff. October 1, 2013; August 1, 1998; January 1,
1994; May 1, 1992; June 1, 1989; July 1, 1982;

(a) Any person possessing source material, or devices
containing source material, in quantities not exceeding the limits of 10 CFR 40.13(a)
through (c)(8) shall be exempt from the requirement for a radioactive materials
license and shall comply with the provisions of 10 CFR 40.13.

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) No person shall introduce radioactive material into a
product or material knowing or having reason to believe that it will be
transferred to persons exempt under Paragraph (d) of this Rule or equivalent
regulations of the U.S. Nuclear Regulatory Commission or any agreement state,
except in accordance with a specific license issued by the Nuclear Regulatory
Commission pursuant to 10 CFR 32.11.

(b) A manufacturer, processor, or producer of a product or
material is exempt from the requirements for a license set forth in the rules
of this Section to the extent that this person transfers radioactive material
contained in a product or material in concentrations not in excess of those
specified in Paragraph (d) of this Rule, and introduced into the product or
material by a licensee holding a specific license issued by the U.S. Nuclear
Regulatory Commission expressly authorizing such introduction. This exemption
does not apply to the transfer of byproduct material contained in any food,
beverage, cosmetic, drug, or other commodity designed for ingestion or
inhalation by, or application to, a human being.

(c) This Rule shall not be deemed to authorize the import
of radioactive material or products containing radioactive material.

(d) Except as provided in Paragraph (a) and (b) of this
Rule, any person is exempt from these Rules to the extent that such person
receives, possesses, uses, transfers, owns, or acquires products or materials
containing radioactive material in concentrations not in excess of those listed
in the following table:

EXEMPT CONCENTRATIONS

Column II

Column I Liquid
and

Gas solid

Element concentration concentration

(atomic number) Isotope microcurie/ml microcurie/ml

Antimony (51) Sb 122 3X10-4

Sb 124 2X10-4

Sb 125 1X10-3

Argon (18) Ar 37 1X10-3

Ar 41 4X10-7

Arsenic (33) As 73 5X10-3

As 74 5X10-4

As 76 2X10-4

As 77 8X10-4

Barium (56) Ba 131 2X10-3

Ba 140 3X10-4

Beryllium (4) Be 7 2X10-2

Bismuth (83) Bi 206 4X10-4

Bromine (35) Br 82 4X10-7 3X10-3

Cadmium (48) Cd 109 2X10-3

Cd 115m 3X10-4

Cd 115 3X10-4

Calcium (20) Ca 45 9X10-5

Ca 47 5X10-4

Carbon (6) C 14 1X10-6 8X10-3

Cerium (58) Ce 141 9X10-4

Ce 143 4X10-4

Ce 144 1X10-4

Cesium (55) Cs 131 2X10-2

Cs 134m 6X10-2

Cs 134 9X10-5

Chlorine (17) Cl 38 9X10-7 4X10-3

Chromium (24) Cr 51 2X10-2

Cobalt (27) Co 57 5X10-3

Co 58 1X10-3

Co 60 5X10-4

Copper (29) Cu 64 3X10-3

Dysprosium (66) Dy 165 4X10-3

Dy 166 4X10-4

Erbium (68) Er 169 9X10-4

Er 171 1X10-3

Europium (63) Eu 152 6X10-4

(Half-life =9.2
Hrs.)

Eu 155 2X10-3

Fluorine (9) F 18 2X10-6 8X10-3

Gadolinium (64) Gd 153 2X10-3

Gd 159 8X10-4

Gallium (31) Ga 72 4X10-4

Germanium (32) Ge 71 2X10-2

Gold (79) Au
196 2X10-3

Au 198 5X10-4

Au 199 2X10-3

Hafnium (72) Hf 181 7X10-4

Hydrogen (1) H 3 5X10-6 3X10-2

Indium (49) In 113m 1X10-2

In 114m 2X10-4

Iodine (53) I 126 3X10-9 2X10-5

I 131 3X10-9 2X10-5

I 132 8X10-8 6X10-4

I 133 1X10-8 7X10-5

I 134 2X10-7 1X10-3

Iridium (77) Ir 190 2X10-3

Ir 192 4X10-4

Ir 194 3X10-4

Iron (26) Fe
55 8X10-3

Fe 59 6X10-4

Krypton (36) Kr 85m 1X10-6

Kr 85 3X10-6

Lanthanum (57) La 140 2X10-4

Lead (82) Pb
203 4X10-3

Lutetium (71) Lu 177 1X10-3

Manganese (25) Mn 52 3X10-4

Mn 54 1X10-3

Mn 56 1X10-3

Mercury (80) Hg 197m 2X10-3

Hg 197 3X10-3

Hg 203 2X10-4

Molybdenum (42) Mo 99 2X10-3

Neodymium (60) Nd 147 6X10-4

Nd 149 3X10-3

Nickel (28) Ni 65 1X10-3

Niobium (Columbium)(41) Nb 95 1X10-3

Nb 97 9X10-3

Osmium (76) Os 185 7X10-4

Os 191m 3X10-2

Os 191 2X10-3

Os 193 6X10-4

Palladium (46) Pd 103 3X10-3

Pd 109 9X10-4

Phosphorus (15) P 32 2X10-4

Platinum (78) Pt 191 1X10-3

Pt 193m 1X10-2

Pt 197m 1X10-2

Pt 197 1X10-3

Potassium (19) K 42 3X10-3

Praseodymium (59) Pr 142 3X10-4

Pr 143 5X10-4

Promethium (61) Pm 147 2X10-3

Pm 149 4X10-4

Rhenium (75) Re 183 6X10-3

Re 186 9X10-4

Re 188 6X10-4

Rhodium (45) Rh 103m 1X10-1

Rh 105 1X10-3

Rubidium (37) Rb 86 7X10-4

Ruthenium (44) Ru 97 4X10-4

Ru 103 8X10-4

Ru 105 1X10-3

Ru 106 1X10-4

Samarium (62) Sm 153 8X10-4

Scandium (21) Sc 46 4X10-4

Sc 47 9X10-4

Sc 48 3X10-4

Selenium (34) Se 75 3X10-3

Silicon (14) Si
31 9X10-3

Silver (47) Ag
105 1X10-3

Ag 110m 3X10-4

Ag 111 4X10-4

Sodium (11) Na 24 2X10-3

Strontium (38) Sr 85 1X10-4

Sr 89 1X10-4

Sr 91 7X10-4

Sr 92 7X10-4

Sulfur (16) S 35 9X10-8 6X10-4

Tantalum (73) Ta 182 4X10-4

Technetium (43) Tc 96m 1X10-1

Tc 96 1X10-3

Tellurium (52) Te 125m 2X10-3

Te 127m 6X10-4

Te 127 3X10-3

Te 129m 3X10-4

Te 131m 6X10-4

Te 132 3X10-4

Terbium (65) Tb 160 4X10-4

Thallium (81) Tl 200 4X10-3

Tl 201 3X10-3

Tl 202 1X10-3

Tl 204 1X10-3

Thulium (69) Tm 170 5X10-4

Tm 171 5X10-3

Tin (50) Sn
113 9X10-4

Sn 125 2X10-4

Tungsten (Wolfram) (74) W 181 4X10-3

W 187 7X10-4

Vanadium (23) V 48 3X10-4

Xenon (54) Xe
131m 4X10-6

Xe 133 3X10-6

Xe 135 1X10-6

Ytterbium (70) Yb 175 1X10-3

Yttrium (39) Y 90 2X10-4

Y 91m 3X10-2

Y 91 3X10-4

Y 92 6X10-4

Y 93 3X10-4

Zinc (30) Zn
65 1X10-3

Zn 69m 7X10-4

Zn 69 2X10-2

Zirconium (40) Zr 95 6X10-4

Zr 97 2X10-4

Beta or gamma emitting 1X10-10 1X10-6

radioactive material not

listed above with half-life

less than 3 years

(e) In Column I of the table, in Paragraph (d) of this
Rule, values are given only for those materials normally used as gases.

(f) In Column II of the table, in Paragraph (d) of this
Rule, the units, microcuries per gram, are used for solids.

(g) Many radioisotopes disintegrate into isotopes which are
also radioactive. In expressing the concentrations in Paragraph (d) of this
Rule, the activity stated is that of the parent isotope and takes into account
the daughters.

(h) For purposes of this Rule, where a combination of
isotopes is involved, the limit for the combination shall be derived as
follows: Determine for each isotope in the product the ratio between the
concentration present in the product and the exempt concentration established
in Paragraph (d) of this Rule for the specific isotope when not in combination.
The sum of the ratios shall not exceed unity. An example of this is:

(a) Any person possessing radioactive material in
individual quantities specified in 10 CFR 30.18(a) or (b) shall be exempt from
the requirements for a radioactive materials license and shall comply with the
provisions of 10 CFR 30.18(c) through (e).

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Any person possessing items containing radioactive
material listed in 10 CFR 30.15(a)(1) through (9) shall be exempt from the
requirements for a radioactive materials license and shall comply with the
provisions of 10 CFR 30.15.

(b) Any person possessing self-luminous products listed in
10 CFR 30.19(a) shall be exempt from the requirements for a radioactive materials
license and shall comply with the provisions of 10 CFR 30.19.

(c) Any person possessing gas and aerosol detectors listed
in 10 CFR 30.20(a) shall be exempt from the requirements for a radioactive
materials license and shall comply with the provisions of 10 CFR 30.20.

(d) Any person possessing radioactive drugs containing
carbon-14 urea for diagnostic use in humans listed in 10 CFR 30.21(a) shall be
exempt from the requirements for a radioactive materials license and shall
comply with the provisions of 10 CFR 30.21.

(e) Any person possessing industrial devices listed in 10
CFR 30.22(a) shall be exempt from the requirements for a radioactive materials
license and shall comply with the provisions of 10 CFR 30.22.

(f) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) General licenses provided in this Section are effective
without the filing of applications with the agency or the issuance of licensing
documents to the general licensee, although registration with the agency may be
required by the particular general license. The general license is subject to
all other applicable rules in this Chapter and any limitations contained in a
general license document, if issued.

(b) Specific licenses require the submission of an
application to the agency and the issuance of a licensing document by the
agency. The licensee is subject to all applicable rules of this Chapter as
well as any limitations and requirements specified in the licensing document.

(a) Any person possessing source material in quantities
equal to or less than the quantities shown in 10 CFR 40.22(a) shall be issued a
general license in accordance with Rule .0306(a) of this Section, and shall
comply with the provisions of 10 CFR 40.22(b) through (e).

(b) Any person possessing depleted uranium for the purpose
authorized in 10 CFR 40.25(a) shall be issued a general license in accordance
with Rule .0306(a) of this Section, and shall comply with the provisions of 10
CFR 40.25(b) through (e).

(c) Reports required by 10 CFR 40.22(b)(4) or 40.25(c)
shall be sent to the agency at the address shown in Rule .0111 of this Chapter.

(d) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

Any person possessing static elimination devices, or ion
generating tubes containing 500 microcuries or less of Polonium-210, or ion
generating tubes containing 50 millicuries or less of tritium, shall comply
with Rule .0305(a) of this Section.

(a) Any person possessing devices listed in 10 CFR 31.5(a)
meeting the requirements of 10 CFR 31.5(b) shall be issued a general license in
accordance with Rule .0306(a) of this Section, and shall comply with the
provisions of 10 CFR 31.5(c) and (d), except that the fees specified in 10 CFR
31.5(c)(13)(ii) shall not apply to persons issued a general license under this
Rule.

(b) Reports, requests for prior approval to transfer
devices authorized under this Rule, and any other correspondence required by 10
CFR 31.5 shall be sent to the agency at the address listed in Rule .0111 of
this Chapter.

(c) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Any person possessing a specific license issued by the
agency, the U.S. Nuclear Regulatory Commission, or another Agreement State
authorizing the manufacture, installation, or servicing of a device described
in Rule .0309 of this Section shall be authorized to install, service, and
uninstall these devices in accordance with the provisions of 10 CFR 31.6.

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) A general license shall be issued to own, receive,
acquire, possess, and use tritium or promethium‑147 contained in luminous
safety devices for use in aircraft, provided:

(1) each device contains not more than ten
curies of tritium or 300 millicuries of promethium‑147; and

(2) each device has been manufactured,
assembled or imported in accordance with a specific license issued by the U.S.
Nuclear Regulatory Commission, or each device has been manufactured or
assembled in accordance with the specifications contained in a specific license
issued by the agency or an agreement state to the manufacturer or assembler of
the device pursuant to licensing requirements equivalent to those in Section 32.53
of 10 CFR Part 32 of the regulations of the U.S. Nuclear Regulatory Commission.

(b) Persons who own, receive, acquire, possess, or use
luminous safety devices pursuant to the general license in Paragraph (a) of
this Rule are exempt from the requirements of Sections .1000 and .1600 of this
Chapter except for Rules .1645 and .1646 of this Chapter.

(c) This general license does not authorize the
manufacture, assembly, or repair of luminous safety devices containing tritium
or promethium‑147.

(d) This general license does not authorize the ownership,
receipt, acquisition, possession or use of promethium‑147 contained in
instrument dials.

(e) The general license provided in Paragraphs (a) and (b)
of this Rule are subject to the provisions of Rules .0107 to .0111, .0303(a),
.0338, .0343, .0344 and .0346 of this Chapter.

(a) A general license shall be issued to those persons
listed below to own, receive, acquire, possess, use and transfer, in accordance
with the provisions in Paragraphs (c) and (d) of this Rule, americium‑241
in the form of calibration or reference sources:

(1) any person who holds a specific license
issued by the agency which authorizes receipt, possession, use, and transfer of
radioactive material; and

(2) any person who holds a specific license
issued by the U.S. Nuclear Regulatory Commission which authorizes receipt,
possession, use, and transfer of special nuclear material.

(b) A general license to own, receive, possess, use, and
transfer plutonium in the form of calibration or reference sources in
accordance with the provisions in Paragraphs (c) and (d) of this Rule is hereby
issued to any person who holds a specific license which is issued by the agency
and which authorizes receipt, possession, use, and transfer of radioactive
material.

(c) The general licenses in Paragraphs (a) and (b) of this
Rule apply only to calibration or reference sources which have been
manufactured in accordance with the specifications contained in a specific
license issued to the manufacturer or importer of the sources by the U.S.
Nuclear Regulatory Commission pursuant to Section 32.57 of 10 CFR Part 32 or
Section 70.39 of 10 CFR Part 70 or which have been manufactured in accordance
with the specifications contained in a specific license issued to the manufacturer
by the agency or an agreement state pursuant to licensing requirements
equivalent to those contained in Section 32.57 of 10 CFR Part 32 or Section
70.39 of 10 CFR Part 70 of the regulations of the U.S. Nuclear Regulatory
Commission.

(d) The general license provided in Paragraphs (a) and (b)
of this Rule are subject to the provisions of Rules .0107 to .0111, .0303(a),
.0337, .0342, .0343 and .0345 of this Chapter and Sections .1000 and .1600 of
this Chapter. In addition, persons who own, receive, acquire, possess, use, or
transfer one or more calibration or reference sources pursuant to this Rule:

(1) shall not possess at any one time, at any
one location of storage or use, more than five microcuries of americium‑241
and five microcuries of plutonium in the calibration and reference sources;

(2) shall not receive, possess, use, or
transfer a calibration or reference source unless the source, or the storage
container, bears a label which includes the following statement or a
substantially similar statement which contains the information called for in
the following statement:

The receipt, possession, use and transfer of this source,
Model _________________, Serial No. __________________, are subject to a
general license and the regulations of the U.S. Nuclear Regulatory Commission
or of a state with which the Commission has entered into an agreement for the
exercise of regulatory authority. Do not remove this label.

CAUTION -
RADIOACTIVE MATERIAL

THIS SOURCE
CONTAINS

(name of
appropriate radioisotope)

DO NOT TOUCH RADIOACTIVE PORTION OF
THIS SOURCE.

______________________________________________________

(Name of manufacturer or importer)

(3) shall not transfer, abandon, or dispose of
a calibration or reference source except by transfer to a person authorized by
a license issued by the agency, the U.S. Nuclear Regulatory Commission, or an
agreement state and authorizing receipt of the source;

(4) shall store each source, except when being
used, in a closed container adequately designed and constructed to contain
americium‑241 or plutonium which might otherwise escape during storage;
and

(5) shall not use a calibration or reference
source for any purpose other than the calibration of radiation detectors or the
standardization of other sources.

(e) The general licenses in Paragraphs (a) and (b) of this
Rule do not authorize the manufacture or calibration of reference sources
containing americium‑241 or plutonium.

A general license shall be issued to own radioactive
material without regard to quantity. This general license does not authorize
the manufacture, production, transfer, receipt, possession or use of radioactive
material.

(a) A general license shall be issued to any physician,
veterinarian in the practice of veterinary medicine, clinical laboratory or
hospital to receive, acquire, possess, transfer or use the following
radioactive materials for IN VITRO clinical or laboratory tests not involving
internal or external administration of radioactive material, or radiation
therefrom, to human beings or animals:

(1) iodine‑125 in units not exceeding ten
microcuries each;

(2) iodine‑131 in units not exceeding ten
microcuries each;

(3) carbon‑14 in units not exceeding ten
microcuries each;

(4) hydrogen‑3 (tritium) in units not
exceeding 50 microcuries each;

(5) iron‑59 in units not exceeding 20
microcuries each;

(6) cobalt‑57 in units not exceeding ten
microcuries each;

(7) selenium‑75 in units not exceeding
ten microcuries each;

(8) mock iodine‑125 reference or
calibration sources in units not exceeding 0.05 microcuries of iodine‑129
and 0.005 microcurie of americium‑241 each. This general license is
subject to the provisions of Paragraphs (b) to (f) of this Rule.

(b) No person shall receive, acquire, possess, use or
transfer radioactive material pursuant to the general license established in
Paragraph (a) of this Rule until he has filed agency form "Certificate IN
VITRO Testing with Radioactive Material Under General License", with the
agency and received from the agency a validated copy of the agency form with
certification number assigned. The physician, clinical laboratory or hospital
shall furnish on the agency form the following information and such other
information as may be required by the form:

(1) name and address of the physician, clinical
laboratory or hospital;

(2) the location of use;

(3) a statement that the physician, clinical
laboratory or hospital has appropriate radiation measuring instruments to carry
out IN VITRO clinical or laboratory tests with radioactive material as
authorized under the general license in Paragraph (a) of this Rule and that
these tests will be performed only by personnel competent in the use of the
instruments and in the handling of the radioactive material.

(c) A person who receives, acquires, possesses or uses
radioactive material pursuant to the general license established in Paragraph
(a) of this Rule:

(1) shall not possess at any one time, pursuant
to the general license in Paragraph (a) of this Rule at any one location of
storage or use a total amount of iodine‑125, iodine‑131, and iron‑59
in excess of 200 microcuries;

(2) shall store the radioactive material, until
used, in the original shipping container or in a container providing equivalent
radiation protection;

(3) shall use the radioactive material only for
the uses authorized in Paragraph (a) of this Rule;

(4) shall not transfer the radioactive material
to a person who is not authorized to receive it pursuant to a license issued by
the agency, the U.S. Nuclear Regulatory Commission, or an agreement state, nor
transfer the radioactive material in any manner other than in the unopened,
labeled shipping container as received from the supplier; and

(5) shall dispose of the mock iodine‑125
reference or calibration sources described in Subparagraph (a)(8) of this Rule
as required by Rule .1628 of this Chapter.

(d) The general licensee shall not receive, acquire,
possess, or use radioactive material pursuant to Paragraph (a) of this Rule:

(1) except as prepackaged units which are
labeled in accordance with the provisions of a specific license issued by the U.S.
Nuclear Regulatory Commission, or an agreement state which authorizes the
manufacture and distribution of iodine‑125, iodine‑131, carbon‑14,
hydrogen‑3 (tritium), selenium‑75, mock iodine‑125 (of iodine‑129
and americium‑241), or iron‑59 for distribution to persons
generally licensed under Paragraph (a) of this Rule or its equivalent; and

(2) unless the following statement, or a
substantially similar statement which contains the information called for in
the following statement, appears on a label affixed to each prepackaged unit or
appears in a leaflet or brochure which accompanies the package:

(A) This radioactive material may be received, acquired,
possessed, and used only by physicians, clinical laboratories, or hospitals and
only for IN VITRO clinical or laboratory tests not involving internal or
external administration of the material, or the radiation therefrom, to human
beings or animals.

(B) Its receipt, acquisition, possession, use, and
transfer are subject to the regulations and a general license of the United
States Nuclear Regulatory Commission, or, of a state with which the Commission
has entered into an agreement for the exercise of regulatory authority. (Name
of Manufacturer).

(e) The physician, clinical laboratory or hospital
possessing or using radioactive material under the general license in Paragraph
(a) of this Rule shall report in writing to the agency, any changes in the
information furnished in the "Certificate IN VITRO Testing with
Radioactive Material Under General License" agency form within 30 days
after the effective date of the changes.

(f) Any person using radioactive material pursuant to the
general license in Paragraph (a) of this Rule is exempt from the requirements
of Sections .1000 and .1600 of these Rules with respect to radioactive material
covered by the general license. The new drug provisions of the Federal Food,
Drug, and Cosmetic Act also govern the availability and use of any specific
diagnostic drugs in interstate commerce.

(a) A general license shall be issued to own, receive,
acquire, possess, use, and transfer strontium‑90 contained in ice
detection devices, provided each device contains not more than 50 microcuries
of strontium‑90 and each device has been manufactured in accordance with
a specific license issued by the U.S. Nuclear Regulatory Commission or in
accordance with the specifications contained in a specific license issued by
the agency or an agreement state to the manufacturer of the device pursuant to
licensing requirements equivalent to those in Section 32.61 of 10 CFR Part 32
of the regulations of the U.S. Nuclear Regulatory Commission.

(b) Persons who own, receive, acquire, possess, use, or transfer
strontium‑90 contained in ice detection devices pursuant to the general
license in Paragraph (a) of this Rule:

(1) shall, upon occurrence of visually
observable damage, such as a bend or crack or discoloration from overheating to
the device, discontinue use of the device until it has been inspected, tested
for leakage and repaired by a person holding a specific license from the U.S.
Nuclear Regulatory Commission or an agreement state authorizing manufacture or
servicing of the devices; or shall dispose of the device pursuant to the
provisions of Rule .1628 of this Chapter;

(2) shall assure that all labels affixed to the
device at the time of receipt, and bearing a statement which prohibits removal
of the labels, are maintained thereon; and

(3) are exempt from the requirements of
Sections .1000 and .1600 of this Chapter except that such persons shall comply
with the provisions of Rules .1628, .1645 and .1646 of this Chapter.

(c) This general license does not authorize the
manufacture, assembly, disassembly or repair of ice detection devices
containing strontium‑90.

(d) This general license is subject to the provisions of
Rules .0107 to .0111 of this Chapter and Rules .0303(a), .0337, .0342, .0343,
and .0345 of this Section.

(a) Any person transporting or storing byproduct material
for transportation shall be exempt as authorized by 10 CFR 30.13.

(b) Any person transporting or storing source material for
transportation shall be exempt as authorized by 10 CFR 40.12. Any person not
exempt under 10 CFR 40.12 shall be issued a general license in accordance with
Rule .0306(a) of this Section.

(c) Any person transporting or storing special nuclear
material for transportation shall be exempt as authorized by 10 CFR 70.12. Any
person not exempt shall be issued a general license in accordance with Rule
.0306(a) of this Section.

(d) Any person preparing radioactive material for shipment
or transporting radioactive material shall be subject to the provisions of 10
CFR Part 71 as applicable to the shipment and mode of transportation.
Notwithstanding Rule .0117(a)(2)(J) of this Chapter, 10 CFR 71.85(a) through
(c), and 71.91(b) are excluded from incorporation by reference for the purposes
of this Rule.

(e) Notifications required by 10 CFR 71.97 and 10 CFR
73.37(b)(2) shall be made to the Governor's designee as follows:

(3) telephone: (919) 733-4030 from 8 a.m. to 5
p.m. Monday through Friday except State holidays, and (919) 733-3861 at all
other times.

(f) Transportation of special nuclear material by aircraft
shall be prohibited in accordance with 10 CFR 150.21.

(g) Notifications of incidents, accidents, or the loss of
control of radioactive material while in transit or while being stored for
transportation shall be made to the agency in accordance with Rule .0357 of
this Section. Notification of the theft, or loss of radioactive material while
in transit, or while being stored for transportation shall be made to the
agency in accordance with Rule .1645 of this Chapter.

(h) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Applications for specific licenses shall be filed on an
agency form in accordance with G.S. 104E-10(b) in lieu of NRC Form 313, and
shall meet the requirements of 10 CFR 30.32, 30.37, or 30.38 as applicable for
the type of licensing action, except that:

(1) 10 CFR 30.32(e), 35.18(a)(2), the portions
of 36.11 and 39.11 pertaining to payment of fees, 40.31(e), 61.20(c) and
70.21(e) are not incorporated by reference;

(2) the agency may require an applicant to
submit an environmental impact statement to the agency in accordance with Rule
.0108 of this Chapter in lieu of the requirements of 10 CFR 30.32(f), 40.31(f),
40.32(e), 61.10, or 70.23(a); and

(3) applications for activities listed in 10
CFR 150.7 or excepted activities listed in 10 CFR 150.10 shall be filed on NRC
Form 313 and submitted to the U.S. Nuclear Regulatory Commission at the address
shown in 10 CFR 150.4 in lieu of the agency. The NRC Form 313 may be found
online at https://www.nrc.gov/reading-rm/doc-collections/forms/nrc313.pdf.

(b) In addition to Paragraph (a) of this Rule, applications
for a specific license to:

(1) manufacture items containing exempt
quantities of radioactive material or to manufacture exempt quantities of
radioactive material that is not incorporated into a manufactured item shall
meet the applicable requirements of 10 CFR Part 32, Subpart A;

(6) administer radioactive material or
radiation from a licensed source to humans for medical use when a license is
required by 10 CFR 35.11 shall meet the requirements of 10 CFR 35.12 and 35.13,
as applicable to licensed activities. Notifications required by 10 CFR 35.14
shall be sent to the agency at the address shown in Rule .0111 of this Chapter;

(d) Completed applications shall be sent to the agency at
the address shown in Rule .0111 of this Chapter.

(e) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(b) For the purposes of this Rule, "Authorized nuclear
pharmacist" means a pharmacist who:

(1) Meets the requirements in 10 CFR 35.55(a)
and 35.59; or

(2) Is identified as an authorized nuclear
pharmacist on:

(A) A specific license issued by the U.S. Nuclear
Regulatory Commission or Agreement State that authorizes medical use or the
practice of nuclear pharmacy;

(B) A permit issued by the U.S. Nuclear Regulatory
Commission master material licensee that authorizes medical use or the practice
of nuclear pharmacy;

(C) A permit issued by a U.S. Nuclear Regulatory
Commission or Agreement State broad scope medical use license that authorizes
medical use or the practice of nuclear pharmacy; or

(D) A permit issued by a U.S. Nuclear Regulatory
Commission master material license broad scope medical use permittee that
authorizes medical use or the practice of nuclear pharmacy;

(3) Is identified as an authorized nuclear
pharmacist by a commercial nuclear pharmacy that has been authorized by the
U.S. Nuclear Regulatory Commission or Agreement State to identify authorized
nuclear pharmacists; or

(4) Is designated as an authorized nuclear
pharmacist in accordance with 10 CFR 32.72(b)(4).

(c) For the purposes of this Rule, "Authorized
user" means a physician, dentist, or podiatrist who:

(A) A U.S. Nuclear Regulatory Commission or Agreement
State license that authorizes medical use of radioactive material;

(B) A permit issued by a U.S. Nuclear Regulatory
Commission master material licensee that is authorized to permit the medical
use of radioactive material;

(C) A permit issued by a U.S. Nuclear Regulatory
Commission or Agreement State specific licensee of broad scope that is
authorized to permit the medical use of radioactive material; or

(D) A permit issued by a U.S. Nuclear Regulatory
Commission master material license broad scope permittee that is authorized to
permit the medical use of byproduct material.

(d) For the purposes of this Section, "Radiation
safety officer" means an individual who:

(1) Meets the requirements in 10 CFR 35.50(a)
or (c)(1) and 10 CFR 35.59; or

(2) Is identified as a Radiation Safety Officer
on:

(A) A specific medical use license issued by the U.S. Nuclear
Regulatory Commission, or an Agreement State; or

(B) A medical use permit issued by a U.S. Nuclear
Regulatory Commission master material licensee.

(e) License required:

(1) A person shall not manufacture, produce,
acquire, receive, possess, use or transfer radioactive material for medical use
except in accordance with a specific license issued by the agency or as allowed
pursuant to Subparagraphs (e)(2) and (e)(3) of this Rule.

(2) An individual may receive, possess, use, or
transfer radioactive material in accordance with the rules of this Section
under the supervision of an authorized user as provided in this Section unless
prohibited by license condition.

(3) An individual may prepare unsealed
radioactive material for medical use in accordance with the rules of this
Section under the supervision of a pharmacist who is an authorized nuclear
pharmacist or physician who is an authorized user as provided in this Section
unless prohibited by license condition.

(f) A license application for human use of radioactive
material shall be approved if the agency determines that:

(1) The applicant is qualified by reason of
training and experience to use the material in question for the purpose
requested in accordance with these Rules;

(2) The applicant's proposed equipment,
facilities, and procedures are adequate to protect public health from radiation
hazards and minimize radiological danger to life or property;

(3) The issuance of the license will not be
inimical to the health and safety of the public;

(4) The following training and supervisory
relationship are adhered to:

(A) The user of radioisotopes applied to humans for
diagnostic, therapeutic, or investigational purposes shall be a physician
authorized by a condition of a specific license, including a specific license
of broad scope.

(B) An authorized physician may delegate the following only
to persons who are physicians under the supervision of the authorized physician:

(i) The approval of procedures involving the
administration to patients of radiopharmaceuticals or the application to
patients of radiation from radioisotope sources;

(ii) The prescription of the radiopharmaceutical or
source of radiation and the dose or exposure to be administered;

(iii) The determination of the route of
administration; and

(iv) The interpretation of the results of diagnostic
procedures in which radiopharmaceuticals are administered.

(C) The authorized physician shall review the work of
the supervised individual as it pertains to the delegated work in Subparagraph (f)(4)
of this Rule and the records kept reflecting that work; and

(5) the applicant satisfies any applicable
requirements in Rules .0319 to .0322 of this Section.

(g) Subject to the provisions of Subparagraph (f)(4) and
Paragraphs (h) through (k) of this Rule, an authorized physician may permit
technicians and other paramedic personnel to perform the following activities:

(1) Preparation and quality control testing of
radiopharmaceuticals and sources of radiation;

(2) Measurement of radiopharmaceutical doses
prior to administration;

(3) Use of instrumentation for the collection
of data to be used by the physician;

(4) Administration of radiopharmaceuticals and
radiation from radioisotope sources to patients.

(h) Authorized physicians who permit activities to be
performed by technicians and other paramedical personnel pursuant to Paragraph (g)
of this Rule shall:

(1) Prior to giving permission, determine that
the technicians and other paramedical personnel have been properly trained to
perform their duties with training in the following subjects, as applicable to
the duties assigned:

(A) General characteristics of radiation and radioactive
materials;

(B) Physical, chemical, and pharmaceutical
characteristics of each radiopharmaceutical to be used;

(C) Mathematics and calculations basic to the use and
measurement of radioactivity, Radioactivity, including units of radiation dose
and radiation exposure;

(D) Use of radiation instrumentation for measurements
and monitoring including operating procedures, calibration of instruments, and
limitations of instruments;

(E) Principles and practices of radiation protection; and

(F) Additional training in the above subjects, as
appropriate, when new duties are added;

(2) Assure that the technicians and other
paramedical personnel receive retraining in the subjects listed in Subparagraph
(h)(1) of this Rule to maintain proficiency and to keep abreast of developments
in the field of nuclear medical technology;

(3) Keep records showing the bases for the
determinations of proper training;

(4) Retain responsibility as licensee or
authorized user for the satisfactory performance of the activities; and

(5) Review the work of the supervised
individual and the records kept reflecting that work.

(i) Certification in nuclear medicine technology by the
American Registry of Radiologic Technologists or in nuclear medicine technology
by the Nuclear Medicine Technologist Certification Board or the Society of
Nuclear Medicine shall be deemed to satisfy the training requirements in
Subparagraphs (h)(1) and (2) of this Rule.

(j) An applicant for an initial, amended or renewed license
shall state whether he desires to permit technicians or other paramedical
personnel to perform activities pursuant to Paragraph (g) of this Rule. If the
applicant intends to do so, the application shall include a statement of the
activities to be so performed and a description of an adequate program for
training the personnel, including retraining as required to keep abreast of
developments in technology, or for otherwise determining that the personnel are
properly trained to perform their duties.

(k) Whenever a technician or other paramedical person
administers a radiopharmaceutical to a patient by injection, a physician shall
be accessible. That physician is not required to be authorized by the agency
to be a user of radioisotopes.

(l) A licensee that permits the receipt, possession, use,
or transfer of radioactive material by an individual under the supervision of
an authorized user shall:

(1) In addition to the requirements in Rule
.1003 of this Chapter, instruct the supervised individual in the licensee's
written radiation protection procedures, written directive procedures, this
Chapter, and license conditions with respect to the use of radioactive
material; and

(2) Require the supervised individual to follow
the instructions of the supervising authorized user for medical uses of
radioactive material, written radiation protection procedures established by
the licensee, written directive procedures, rules of this Chapter, and license
conditions with respect to the medical use of radioactive material.

(m) A licensee that permits the preparation of radioactive
material for medical use by an individual under the supervision of an
authorized nuclear pharmacist or physician who is an authorized user shall:

(1) In addition to the requirements in
Paragraph (h) of this Rule and Rule .1003 of this Chapter, instruct the
supervised individual in the preparation of radioactive material for medical
use, as appropriate to that individual's involvement with radioactive material;
and

(2) Require the supervised individual to follow
the instructions of the supervising authorized user or authorized nuclear
pharmacist regarding the preparation of radioactive material for medical use,
written radiation protection procedures established by the licensee, the rules
of this Chapter, and license conditions.

(n) A licensee that permits supervised activities under
Paragraphs (g) and (h) of this Rule is responsible for the acts and omissions
of the supervised individual.

(o) A licensee's management shall appoint a Radiation
Safety Officer (RSO) who agrees in writing to be responsible for implementing
the radiation safety program. The licensee, through the RSO, shall ensure that
radiation safety activities are being performed in accordance with approved
procedures and regulatory requirements in the daily operation of the licensee's
radioactive material program.

(p) A licensee shall establish in writing the authority,
duties and responsibilities of the Radiation Safety Officer.

(r) In addition to the requirements in Rule .1003 of this
Chapter, the licensee shall provide radiation safety instruction, initially and
at least annually, to personnel caring for patients or human research subjects
who cannot be released in accordance with the requirements of Rule .0358 of
this Section. To satisfy this requirement, the instruction must be
commensurate with the duties of the personnel and include:

(1) Patient or human research subject control;

(2) Visitor control, including:

(A) Routine visitation to hospitalized individuals in
accordance with the provisions of Rule .1611(a)(1) of this Chapter; and

(B) Visitation authorized by Rule .1611(e) of this
Chapter;

(3) Contamination control;

(4) Waste control; and

(5) Notification of the Radiation Safety
Officer, or his designee, and an authorized user if the patient or the human
research subject has a medical emergency or dies.

(s) The licensee shall retain records of the radiation
safety instructions required by Paragraphs (l), (m), and (r) for three years.
The record must include:

(a) Except as provided in Rules .0302 to .0315 and .0320 of
this Section, all receipt, possession, use, storage and disposal of radioactive
material in a hospital shall be pursuant to the provisions of a specific
license issued to the hospital.

(b) An application by a hospital for a specific license for
human use of radioactive material will be approved if:

(1) the applicant satisfies the general
requirements in Rule .0318 of this Section;

(2) the applicant has appointed a medical
isotopes committee of at least three members to evaluate all proposals for
research, diagnostic and therapeutic use of radioisotopes within the hospital;

(3) membership of the committee required in
Subparagraph (b)(2) of this Rule includes an authorized user from each
department where radioactive material is used, a representative of the nursing
staff, a representative of the institution's management and a person trained in
radiation safety;

(4) the applicant possesses adequate facilities
for the clinical care of patients;

(5) the physician designated on the application
as the individual user has substantial experience in the proposed use, handling
and administration of radioisotopes and, where applicable, the clinical
management of radioactive patients; and

(6) when the application is for a license to
use unspecified quantities or multiple types of radioactive material, the
applicant has previously received a reasonable number of licenses for a variety
of radioactive materials for a variety of human uses.

(a) An application by an individual physician or a group of
physicians for a specific license for human use of radioactive material shall
be approved if:

(1) the applicant satisfies the general
requirements in Rule .0318 of this Section;

(2) The application is for use in the
applicant's practice in an office(s) outside a medical institution;

(3) the applicant has access to a hospital
possessing adequate facilities to hospitalize and monitor the applicant's
radioactive patients whenever it is advisable;

(4) the applicant has experience, which meets
the requirements of the applicable sections of 10 CFR Part 35, in the proposed
use, the handling and administration of radioisotopes, and where applicable,
the clinical management of radioactive patients; and

(5) the physician(s) furnishes suitable
evidence of experience along with the application, except that a statement from
the medical isotope committee in the hospital where the applicant acquired
experience, indicating its amount and nature, may be submitted as evidence of
experience. 10 CFR Part 35 provides the requirements that meet the test for
suitable evidence of experience.

(b) The agency shall not approve an application by an individual
physician or group of physicians for a specific license to receive, possess or
use radioactive material on the premises of a hospital unless:

(1) The use of radioactive material is limited
to:

(A) the administration of radiopharmaceuticals for
diagnostic or therapeutic purposes;

(B) the performance of diagnostic studies on patients to
whom a radiopharmaceutical has been administered;

(3) the physicians designated in the
application as individual users have clinical experience as required by Rule
.0117(a)(2) of this Chapter;

(4) the physicians and all other personnel who
will be involved in the preparation and use of radioactive material have
training and experience in the handling of unsealed radioactive material
appropriate to their use of radioactive material and as required by Rule
.0117(a)(2) of this Chapter;

(5) the applicant has radiation safety
operating procedures for handling and disposal of the radioactive material that
provide protection to the workers, the public and the environment from
radiation exposure and radioactive contamination; and

(6) the applicant has a clinical procedures
manual appropriate for the licensed activities.

(b) Any person authorized by Rules .0318, .0319, .0320,
.0322, or .0324 of this Section for medical use of radioactive material may
receive, possess and use any of the following radioactive material for check,
calibration, transmission and reference use:

(2) Sealed sources, not exceeding 30 mCi (1.11
GBq) each, redistributed by a licensee authorized to redistribute the sealed
sources manufactured and distributed by a person licensed under 10 CFR 32.74,
providing the redistributed sealed sources are in the original packaging and
shielding and are accompanied by the manufacturer's approved instructions;

(3) Any radioactive material with a half-life
not longer than 120 days in individual amounts not to exceed 15 mCi (0.56 GBq);

(4) Any radioactive material with a half-life
greater than 120 days in individual amounts not to exceed the smaller of 200
microcuries (µCi) (7.4 Megabecquerel (MBq)) or 1000 times the quantities in
Appendix C of 10 CFR Part 20; and

(5) Technetium-99m in amounts as needed.

(c) Any licensee who possesses sealed sources as
calibration and reference sources pursuant to Paragraph (b) of this Rule shall
test each source for leakage and contamination prior to initial use and at
intervals not to exceed six months or at longer intervals as approved by the
U.S. Nuclear Regulatory Commission or an Agreement State in the source specific
Sealed Source and Device Registry sheet. If there is reason for the licensee to
suspect that a sealed source may have been damaged, or might be leaking, it
shall be tested for leakage before further use.

(d) Leak test results shall be recorded in units of
microcuries and maintained for inspection by the agency.

(e) Any licensee who possesses and uses calibration and
reference sources pursuant to Paragraph (b) of this Rule shall:

(1) follow the radiation safety and handling
instructions that are required by the licensing agency to be furnished by the
manufacturer on the label attached to the source or permanent container thereof
or in the leaflet or brochure that accompanies the source;

(2) maintain such instructions in a legible and
conveniently available form; and

(3) conduct a quarterly physical inventory to
account for all sources received and possessed under the license. Records of
the inventories shall be maintained for inspection by the agency and shall
include the quantities and kinds of radioactive material, location of the
sources and the date of the inventory.

(f) Any licensee who is licensed pursuant to Rules .0318,
.0319, .0320, or .0324 of this Section for medical use of unsealed radioactive
material also is authorized to use radioactive material under the general
license in Rule .0314 of this Chapter for the specified in vitro uses without
filing agency forms as required by Rule .0314(b) of the Chapter, provided that
the licensee is subject to the other provisions of that Rule.

(g) For each individual receiving radiopharmaceutical
therapy and hospitalized because the individual cannot be released in
accordance with Rule .0358 of this Section, a licensee shall:

(1) provide a private room with a private
sanitary facility;

(2) post on the individual's door a
"Radioactive Materials" sign and note on the door or the individual's
chart, where and how long visitors may stay in the individual's room;

(3) either monitor material or items removed
from the individual's room to determine that their radioactivity cannot be
distinguished from the natural background radiation level with a radiation detection
survey instrument set on its most sensitive scale and with no interposed
shielding, or handle them as radioactive waste; and

(4) notify the Radiation Safety Officer and
authorized user as soon as feasible if the individual has a medical emergency
and immediately after the determination that the patient died.

(a) In addition to the requirements set forth in Rule
.0318, .0319, or .0320 of this Section, a specific license for human use of
sealed sources shall be issued only if the applicant, or if the application is
made by an institution, the individual user:

(1) Has training and experience as required by 10
CFR 35.490 or 10 CFR 35.690; and

(2) Is a physician.

(b) The licensee shall comply with the provisions of
Section .0700 of this Chapter and the requirements of Subpart H of 10 CFR Part
35.

(c) For medical use, a licensee may only use:

(1) Sealed sources or devices manufactured,
labeled, packaged and distributed in accordance with a license issued under 10
CFR Part 30 and 10 CFR 32.74 or equivalent requirements of an Agreement State;

(2) Sealed sources or devices noncommercially
transferred from a licensee licensed pursuant to Section .0300 of this Chapter,
10 CFR Part 35, or an Agreement State medical use licensee;

(3) Teletherapy sources manufactured and
distributed in accordance with 10 CFR Part 30 or the equivalent requirements of
an Agreement State; or

(B) In research in accordance with an active
Investigational Device Exemption (IDE) application accepted by the FDA provided
the requirements of 10 CFR 35.49(a) are met.

(d) In addition to the requirements in Rule .1003 of this
Chapter, the licensee shall provide radiation safety instruction prior to
assignment and at least annually, to personnel caring for patients or human
research subjects who are receiving brachytherapy and cannot be released in
accordance with Rule .0358 of this Section. To satisfy this requirement the
instruction must be commensurate with the duties of the personnel and include:

(1) Size and appearance of the brachytherapy
sources;

(2) Safe handling and shielding instructions;

(3) Patient or human research subject control;

(4) Visitor control, including both:

(A) Routine visitation to hospitalized individuals in
accordance with the provisions of Rule .1611(a)(1) of this Chapter;

(B) Visitation authorized by Rule .1611(e) of this Chapter;
and

(5) Notification of the Radiation Safety
Officer, or his designee, and an authorized user if the patient or the human
research subject has a medical emergency or dies.

(e) The licensee shall retain records of the radiation
safety instruction required in Paragraph (d) of this Rule for three years. The
record must include:

In addition to the requirements set forth in Rule .0317 of
this Section, a specific license for use of sealed sources in industrial
radiography shall be issued if:

(1) The applicant has a program for training
radiographers and radiographers' assistants to meet the requirements of this
Rule and Rule .0510 of this Chapter and submits to the agency a schedule or
description of such program which specifies the:

(a) initial training;

(b) periodic training;

(c) on‑the‑job training;

(d) means to be used by the licensee to
determine the radiographer's knowledge and understanding of and ability to
comply with agency regulations and licensing requirements, and the operating
and emergency procedures of the applicant; and

(e) means to be used by the licensee to
determine the radiographer's assistant's knowledge and understanding of and
ability to comply with the operating and emergency procedures of the applicant;

(2) The applicant has established and submits to the
agency satisfactory written operating and emergency procedures described in
Rule .0513 of this Chapter;

(3) The applicant has established and submits to the
agency a description of its inspection program which is adequate to ensure that
each radiographer and radiographer assistant follows the rules in this Chapter
and the applicant's operating and emergency procedures.

(4) The inspection program described in the applicant's
procedures shall include:

(a) observation of the performance of each
radiographer and radiographer's assistant during an actual industrial
radiographic operation at the intervals not to exceed six months; provided
that, if a radiographer or a radiographer's assistant has not participated in a
radiographic operation for more than six months since the last inspection, that
individual's performance must be observed and recorded by a practical
examination before the individual participates in a radiographic operation;

(b) in those operations where a single individual
serves as both radiographer and Radiation Safety Officer, and performs all
radiography operations, an inspection program is not required; and

(c) the retention of inspection records on the
performance of radiographers or radiographers' assistants for three years;

(5) The applicant submits to the agency a description
of his overall organizational structure pertaining to the industrial
radiography program, including specified delegations of authority and
responsibility for operation of the program;

(6) The applicant who desires to conduct his own leak
tests has established procedures to be followed in leak testing sealed sources
for possible leakage and contamination sufficient to detect 0.005 microcuries
of removable contamination on the source, and submits to the agency a
description of the procedures, including:

(a) instrumentation to be used;

(b) method of performing tests, e.g., points on
equipment to be tested and method of taking tests; and

(c) pertinent experience of the person who will
perform the test; and

(7) The licensee conducts a program for inspection and
maintenance of radiographic exposure devices and storage containers to assure
proper functioning of components important to safety.

(a) In addition to the requirements set forth in Rule .0317
of this Section, a specific license of broad scope for radioactive material
will be issued if:

(1) the applicant has engaged in a wide variety
of activities involving the use of many different types of radioactive material
in a variety of physical and chemical forms; and

(2) the applicant has established
administrative controls and provisions relating to organization and management,
procedures, record keeping, material control and accounting, and management
review that are necessary to assure safe operations, including:

(A) the establishment of a radiation safety committee
composed of such persons as a radiation safety officer, a representative of management,
and persons trained and experienced in the safe use of radioactive material;

(B) the appointment of a radiation safety officer who is
qualified by training and experience in radiation protection, and who is
available for advice and assistance on radiation safety measures; and

(C) the establishment of appropriate administrative
procedures to assure:

(i) control of procurement and use of radioactive
material;

(ii) completion of safety evaluations of proposed
uses of radioactive material which takes into consideration such matters as the
adequacy of facilities and equipment, training and experience of the user, and
the operating or handling procedures; and

(iii) review, approval, and recording by the
radiation safety committee of safety evaluations of proposed uses prepared in
accordance with Part (a)(2)(C) of this Rule prior to use of the radioactive
material.

(3) Unless specifically authorized pursuant to
other rules of this Section, persons licensed under this Rule shall not:

(B) receive, acquire, own, possess, use, or transfer
devices containing 100,000 curies or more of byproduct material in sealed
sources used for irradiation of materials;

(C) conduct activities for which a specific license
issued by the agency under the rules of this Section is required; or

(D) add or cause the addition of radioactive material to
any food, beverage, cosmetic, drug, or other product designed for ingestion or
inhalation by, or application to, a human being.

(4) Each specific license of broad scope issued
under this Rule shall be subject to the condition that radioactive material
possessed under the license may only be used by, or under the direct
supervision of, individuals approved by the licensee's radiation safety
committee.

(b) In addition to the requirements set forth in Rule .0319
of this Section, a specific license of broad scope for radioactive material,
human use, will be issued only if:

(1) the applicant has appointed a radiation
safety committee as required in Part (a)(2)(A) of this Rule, except that this
committee shall evaluate all proposals for research, diagnostic and therapeutic
use of radioactive material within the medical facility;

(2) membership of the committee consists of
physicians specializing in nuclear medicine, diagnostic radiology, clinical
pathology, and a pharmacist specializing in radiopharmacy, someone competent in
radiation safety and a representative of the hospital management; and

(3) the applicant for a medical radioactive
materials license of broad scope has an ongoing teaching program with interns
and residents associated with a four‑year medical school.

An application for a specific license authorizing the
manufacture and initial distribution of devices containing byproduct material
to persons exempt from licensing under Rule .0305(c) of this Section shall
comply with the provisions of Rule .0317(a), (b)(1), (c), and (d) of this
Section as applicable to the licensed activities.

An application for a specific license authorizing the
manufacture and initial transfer of devices containing byproduct material to
persons generally licensed under Rule .0309 of this Section shall comply with
the provisions of Rule .0317(a), (b)(2), (c), and (d) of this Section as
applicable to the licensed activities.

An application for a specific license authorizing the
manufacture, assembly, repair, and initial transfer devices containing
byproduct material to persons generally licensed under Rule .0311 of this
Section shall comply with the provisions of Rule .0317(a), (b)(2), (c), and (d)
of this Section as applicable to the licensed activities.

An application for a specific license authorizing the
manufacture and initial transfer of calibration or reference sources for
distribution to persons generally licensed under Rule .0312 of this Section
shall comply with the provisions of:

(1) Rule .0317(a), (c), and (d) of this Section;

(2) Rule .0317(b)(2) of this Section for calibration or
reference sources containing byproduct material; and

(3) Rule .0317(b)(12) of this Section for calibration
or reference sources containing plutonium.

An application for a specific license authorizing the
manufacture and initial transfer of devices containing byproduct material to
persons generally licensed under Rule .0314 of this Section shall comply with
the provisions of Rule .0317(a), (b)(2), (c), and (d) of this Section as
applicable to the licensed activities.

An application for a specific license authorizing the
manufacture and initial transfer of generally licensed ice detection devices
for transfer to a person generally licensed under Rule .0315 of this Section
shall comply with the provisions of Rule .0317(a), (b)(2), (c), and (d) of this
Section as applicable to the licensed activities.

(a) An application for a specific license to manufacture
and distribute radiopharmaceuticals containing radioactive material for use by
persons licensed pursuant to Rules .0318, .0319, or .0320 of this Section for medical
use shall be approved if the applicant meets the following conditions:

(1) the applicant satisfies the requirements of
Rule .0317 of this Section; and

(2) the applicant meets the applicable
requirements in Section 32.72 of 10 CFR Part 32, and Section 30.32(j) of 10 CFR
Part 30.

(b) Authorization under this Rule to produce Positron
Emission Tomography (PET) radioactive drugs for noncommercial transfer to
medical use licensees in its consortium does not relieve the licensee from
complying with applicable FDA, other Federal, and State requirements governing
radioactive drugs.

(c) Each licensee authorized under this Rule to produce PET
radioactive drugs for noncommercial transfer to medical use licensees in its
consortium shall:

(1) satisfy the labeling requirements in Rule
.1626 of this Chapter for each PET radioactive drug transport radiation shield
and each syringe, vial, or other container used to hold a PET radioactive drug
intended for noncommercial distribution to members of its consortium; and

(2) possess and use instrumentation to measure
the radioactivity of the PET radioactive drugs intended for noncommercial
distribution to members of its consortium and meet the procedural,
radioactivity measurement, instrument test, instrument check, and instrument
adjustment requirements in this Rule.

(d) A licensee that is a pharmacy authorized under Rule
.0333 of this Section to produce PET radioactive drugs for noncommercial
transfer to medical use licensees in its consortium shall require that any
individual that prepares PET radioactive drugs be:

(1) an authorized nuclear pharmacist that meets
the requirements in Rule .0318 of this Section; or

(2) an individual under the supervision of an
authorized nuclear pharmacist as specified in Rule .0318 of this Section.

(e) A pharmacy authorized under this Rule to produce PET
radioactive drugs for noncommercial transfer to medical use licensees in its
consortium that allows an individual to work as an authorized nuclear
pharmacist shall meet the requirements of Rule .0318 of this Section.

An application for a specific license to manufacture and
distribute generators and reagent kits containing radioactive material for
preparation of radiopharmaceuticals by persons licensed pursuant to Rule .0321
of this Section for the generators, reagent kits and associated medical uses shall
be approved if the applicant meets the following conditions:

(1) the applicant satisfies the general requirements of
Rule .0317 of this Section; and

(2) the applicant satisfies the applicable requirements
in Section 32.73 of 10 CFR Part 32 or their agreement state equivalent.

An application for a specific license authorizing the
manufacture and initial transfer of products containing depleted uranium to
persons generally licensed under Rule .0307(b) of this Section, shall comply
with the provisions of Rule .0317(a), (b)(9), (c), and (d) of this Section as
applicable to the licensed activities.

(a) An application for a specific license shall be
approved, and a specific license issued, or amended by the agency if the agency
determines that the applicant satisfies the provisions of 10 CFR 30.33(a)(1)
through (4), 30.39, 40.32(a) through (f), and 70.23(a)(1) through (6) as
applicable to the licensed activities, and any additional requirements in:

(2) 10 CFR 32.51, 32.53, 32.57, 32.61, and
32.71 as applicable to the manufacturing and distribution of generally licensed
items and devices listed in 10 CFR Part 32, Subpart B;

(3) 10 CFR 32.72 and 32.74 as applicable to the
manufacturing and distribution of radioactive drugs, sources, or devices listed
in 10 CFR Part 32, Subpart C;

(4) 10 CFR 33.13 through 33.15, and 33.17 as
applicable to activities of broad scope;

(5) 10 CFR 34.13 for industrial radiography;

(6) 10 CFR 35.18 for the medical use of
radioactive materials;

(7) 10 CFR 36.13 for the use of sealed sources
to irradiate materials;

(8) 10 CFR 39.13, 39.15, and 39.17 for the use
of radioactive materials in well logging;

(9) 10 CFR 40.34 for the use of source material
in the manufacture and initial transfer of devices containing depleted uranium
to a person generally licensed under Rule .0307(b) of this Section;

(10) 10 CFR 40.52 for the use of source material
in the manufacture of exempt devices listed in Rule .0305 of this Section;

(11) 10 CFR 40.54 for the initial transfer of
source material to a person generally licensed under Rule .0307(a) of this
Section;

(12) 10 CFR 61.23(a) through (h), and (k), and
Section .1200 of this Chapter for the receipt, possession, transfer, or
disposal of radioactive waste received from another person; and

(13) 10 CFR 70.31(a) and (b) for the use of
special nuclear material.

(b) An application for a new or amended Sealed Source and
Device Registration certificate shall be approved by the agency, and a new or
amended Sealed Source and Device Registration certificate issued in accordance
with 10 CFR 32.210(d) and (e).

(c) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) All licenses issued by the agency for activities
authorized under therulesof this Section are subject to the terms
and conditions listed in 10 CFR 30.34(a) through (d), and 30.34(e)(2) through
(j)(4). In addition to these terms and conditions, licenses of broad scope are
subject to the terms and conditions listed in 10 CFR 33.17.

(b) All licenses issued by the agency authorizing the
possession and use of source material are subject to the terms and conditions
listed in 10 CFR 40.35, 40.41, 40.46, 40.53, 40.55, and 40.56.

(c) All licenses issued by the agency authorizing the
receipt, possession, or disposal of radioactive waste received from another
person are subject to the terms and conditions listed in 10 CFR 61.24, 61.25,
and the Rules in Section .1200 of this Chapter.

(d) All licenses issued by the agency authorizing the
possession and use of special nuclear material are subject to the terms and
conditions of 10 CFR 70.32.

(e) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Each specific license expires at the end of the day on
the expiration date stated in the license unless the licensee has filed an
application for renewal, as required in Rule .0340 of this Section, not less
than 30 days before the expiration date stated in the existing license. If an
application for renewal has been filed at least 30 days prior to the expiration
date stated in the existing license, the existing license expires at the end of
the day on which the agency makes a final determination to deny the renewal
application or, if the determination states an expiration date, the expiration
date stated in the determination.

(b) Each specific license revoked by the agency, as
provided for in Rule .0344 of this Section, expires at the end of the day on
the date of the agency's final determination to revoke the license, or on the
expiration date stated in the determination, or as otherwise provided by agency
order.

(c) Each specific license continues in effect, beyond the
expiration date if necessary, with respect to possession of residual
radioactive material present as contamination until the agency notifies the
licensee in writing that the license is terminated. During this time, the
licensee shall:

(1) limit actions involving radioactive
material to those related to decommissioning; and

(2) continue to control entry to restricted
areas until they are suitable for release for unrestricted use and the agency
notifies the licensee in writing that the license is terminated.

(d) Within 60 days of the occurrence of any of the
following, each licensee shall provide notification to the agency in writing of
such occurrence, and either begin decommissioning its site, or any separate
building or outdoor area that contains residual radioactivity so that the
building or outdoor area is suitable for release in accordance with Commission
requirements, or submit within 12 months of notification a decommissioning
plan, if required by Subparagraph (g)(1) of this Rule, and begin
decommissioning upon approval of that plan if:

(1) The license has expired pursuant to
Paragraphs (a) or (b) of this Rule;

(2) The licensee has decided to permanently
cease principal activities at the entire site or in any separate building or
outdoor area that contains residual radioactivity such that the building or
outdoor area is unsuitable for release in accordance with Commission
requirements;

(3) No principal activities under the license
have been conducted for a period of 24 months; or

(4) No principal activities have been conducted
for a period of 24 months in any separate building or outdoor area that
contains residual radioactivity such that the building or outdoor area is
unsuitable for release in accordance with Commission requirements.

(e) Coincident with the notification requirements set forth
in Paragraph (d) of this Rule, the licensee shall maintain in effect all
decommissioning financial assurances established by the licensee pursuant to
Rule .0353 of this Section in conjunction with a license issuance or renewal,
or as required by this Rule. The amount of the financial assurance must be
increased, or may be decreased, as appropriate, to cover the detailed cost
estimate for decommissioning established in Paragraph (g) of this Rule.

(1) Any licensee who has not provided financial
assurance to cover the detailed cost estimate submitted with the
decommissioning plan shall do so when this Rule becomes effective.

(2) Following agency approval of the decommissioning
plan, a licensee may reduce the amount of the financial assurance as
decommissioning proceeds and radiological contamination is reduced at the site
with the approval of the agency.

(f) The agency may grant a request to extend the time
periods required in Paragraph (d) of this Rule if the agency determines that
this relief is not detrimental to the public health and safety and is otherwise
in the public interest. The request shall be submitted to the agency no later
than 30 days before notification pursuant to Paragraph (d) of this Rule. The
schedule for decommissioning set forth in Paragraph (d) of this Rule may not
commence until the agency has made a determination on the licensee's request.

(g) A decommissioning plan shall be submitted if required
by license condition or if the procedures and activities necessary to carry out
decommissioning of the site or separate building or outdoor area have not been
previously approved by the agency and these procedures could increase potential
health and safety impacts to workers or to the public, such as in any of
following cases:

(1) Procedures would involve techniques not
applied routinely during cleanup or maintenance operations;

(2) Workers would be entering areas not
normally occupied where surface contamination and radiation levels are
significantly higher than routinely encountered during operation;

(3) Procedures could result in significantly
greater airborne concentrations of radioactive materials than are present
during operation; or

(4) Procedures could result in significantly
greater releases of radioactive material to the environment than those
associated with operation. For the purpose of Subparagraphs (g)(2)-(4) of this
Rule, significantly higher or significantly greater is defined as an increase
likely to result in either an increase in radiation exposure to workers or the
public in excess of one percent of their respective annual radiation exposure
limit.

(h) The agency may approve an alternate schedule for
submittal of a decommissioning plan required pursuant to Paragraph (d) of this
Rule if the agency determines that the alternative schedule is necessary to the
effective conduct of decommissioning operations and presents no undue risk from
radiation to the public health and safety and is otherwise in the public
interest.

(i) Procedures such as those listed in Paragraph (g) of
this Rule with potential health and safety impacts may not be carried out prior
to agency approval of the decommissioning plan.

(j) The proposed decommissioning plan for the site or
separate building or outdoor area shall include:

(1) A description of the conditions of the site
or separate building or outdoor area sufficient to evaluate the acceptability
of the plan;

(2) A description of planned decommissioning
activities;

(3) A description of methods used to ensure
protection of workers and the environment against radiation hazards during
decommissioning;

(4) A description of the planned final
radiation survey;

(5) An updated detailed cost estimate for
decommissioning, comparison of that estimate with present funds set aside for
decommissioning, and a plan for assuring the availability of adequate funds for
completion of decommissioning; and

(6) For decommissioning plans calling for
completion of decommissioning later than 24 months after plan approval, the
plan shall include a justification for the delay based on the criteria in
Paragraph (m) of this Rule.

(k) The proposed decommissioning plan shall be approved by
the agency if the information therein demonstrates that the decommissioning
will be completed as soon as practicable and that the health and safety of
workers and the public will be protected.

(l) Except as provided in Paragraph (m) of this Rule,
licensees shall complete decommissioning of the site or separate building or
outdoor area as soon as practicable but no later than 24 months following the
initiation of decommissioning. Except as provided in Paragraph (m) of this
Rule, when decommissioning involves the entire site, the licensee shall request
license termination as soon as practicable but no later than 24 months
following the initiation of decommissioning.

(m) The agency may approve a request for an alternative
schedule for completion of decommissioning of the site or separate building or
outdoor area, and license termination if appropriate, if the agency determines
that the alternative is warranted by consideration of the following:

(1) Whether it is technically feasible to
complete decommissioning within the allotted 24 month period;

(2) Whether sufficient waste disposal capacity
is available to allow completion of decommissioning within the allotted 24
month period;

(3) Whether a significant volume reduction in
wastes requiring disposal will be achieved by allowing short-lived
radionuclides to decay;

(4) Whether a significant reduction in
radiation exposure to workers can be achieved by allowing short-lived
radionuclides to decay; and

(5) Other site-specific factors which the
agency may consider appropriate on a case-by-case basis, such as:

(A) regulatory requirements of other government
agencies;

(B) lawsuits;

(C) ground-water treatment activities;

(D) monitored natural ground-water restoration;

(E) actions that could result in more environmental
harm than deferred cleanup; and

(F) other factors beyond the control of the licensee.

(n) As the final step in decommissioning, the licensee
shall:

(1) Certify the disposition of all licensed
material, including accumulated wastes, by submitting a completed
"Certificate of Disposition"; and

(2) Conduct a radiation survey of the premises
where the licensed activities were carried out and submit a report of the
results of this survey unless the licensee demonstrates that the premises are
suitable for release in some other manner. The licensee shall, as appropriate:

(A) Report levels of gamma radiation in units of
microrem (millisieverts) per hour at one meter from surfaces;

(B) Report levels of radioactivity, including alpha and
beta, in units of microcuries per 100 square centimeters (or disintegrations
per minute), removable and fixed, for surfaces; microcuries per milliliter for
water; and picocuries per gram for solids such as soils or concrete; and

(C) Specify the survey instrument(s) used and certify
that each instrument is properly calibrated and tested.

(o) Specific licenses shall be terminated by written notice
to the licensee when the agency determines that:

(1) radioactive material has been properly
disposed;

(2) reasonable effort has been made to
eliminate residual radioactive contamination, if present; and

(3) a radiation survey has been performed which
demonstrates that the premises are suitable for release in accordance with the
requirements for decommissioning described in Rule .1653 of this Chapter, or
other information submitted by the licensee is sufficient to demonstrate that
the premises are suitable for release in accordance with the requirements for
decommissioning described in Rule .1653 of this Chapter.

Applications for amendment of a license shall be filed in
accordance with Rule .0317 of this Section and shall specify the respects in
which the licensee desires his license to be amended and the grounds for such
amendment. The applicant shall submit such other supporting information as
required by the agency.

(a) Any person licensed under the rules of this Section
transferring byproduct material shall comply with the provisions of 10 CFR
30.41.

(b) Any person licensed under the rules of this Section
transferring source material shall comply with the provisions of 10 CFR 40.51.

(c) Any person licensed under the rules of this Section
transferring special nuclear material shall comply with the provisions of 10
CFR 70.42.

(d) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

History Note: Authority G.S. 104E‑7; 104E‑10(b);

Eff. February 1, 1980;

Amended Eff. May 1, 1993; June 1, 1989;

Temporary Amendment Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

(a) All licenses authorizing the receipt, possession, use,
and transfer of byproduct material, and all sealed source and device
registration certificates issued by the agency under the rules of this Section,
are subject to modification by the agency in accordance with 10 CFR 30.61.

(b) All licenses issued by the agency for the receipt,
possession, use, and transfer of source material under the rules of this
Section, are subject to modification by the agency in accordance with 10 CFR
40.71.

(c) All licenses issued by the agency for the receipt,
possession, transfer, or disposal of radioactive waste from another person are
subject to modification by the agency in accordance with the provisions of 10
CFR 61.24.

(d) All licenses issued by the agency for the receipt,
possession, use, and transfer of special nuclear material are subject to
modification by the agency in accordance with 10 CFR 70.81.

(e) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Subject to these Rules, any person who holds a specific
license from the U.S. Nuclear Regulatory Commission or an agreement state, and
issued by the agency having jurisdiction where the licensee maintains an office
for directing the licensed activity and at which radiation safety records are
normally maintained, is hereby granted a general license to conduct the
activities authorized in such licensing document within this state for a period
not in excess of 180 days in any calendar year provided that the following
requirements are satisfied:

(1) The licensing document does not limit the
activity authorized by such document to specified installations or locations;

(2) The out‑of‑state licensee notifies
the agency in writing at least three days prior to engaging in such activity;
such notification shall indicate the location, period, and type of proposed
possession and use within the state, and shall be accompanied by a copy of the
pertinent licensing document; if, for a specific case, the three day period
would impose an undue hardship on the out‑of‑state licensee,
including but not limited to adverse impact on the business of the licensee or
his customer, he may upon application to the agency, obtain permission to
proceed sooner; the agency may waive the requirement for filing additional
written notifications during the remainder of the calendar year following the
receipt of the initial notification from a person engaging in activities under
the general license provided in this Rule if the agency determines that such
written notifications are not necessary to ensure compliance with the rules in
this Chapter or to protect the public;

(3) The out‑of‑state licensee
complies with all applicable rules of the agency and with all the terms and
conditions of his licensing document, except any such terms and conditions
which may be inconsistent with applicable rules of the agency;

(4) The out‑of‑state licensee
supplies such other information as the agency may request; and

(5) The out‑of‑state licensee shall
not transfer or dispose of radioactive material possessed or used under the
general license provided in this Rule except by transfer to a person:

(A) specifically licensed by the agency or by the U.S.
Nuclear Regulatory Commission to receive the material, or

(B) exempt from the requirements for a license for the
material under Rule .0303 of this Section.

(b) Additional reciprocity is provided in Rule .0310 of
this Section.

(c) The agency may withdraw, limit, or qualify its
acceptance of any specific license or equivalent licensing document issued by
another agency, or any product distributed pursuant to such licensing document,
upon determining that the action is necessary in order to prevent undue hazard
to public health and safety or property.

(a) No licensee shall deliver any radioactive material to a
carrier for transport, unless:

(1) The licensee complies with the applicable
requirements of the regulations, appropriate to the mode of transport, of the
U.S. Department of Transportation insofar as such regulations relate to the
packing of radioactive material, and to the monitoring, marking and labeling of
those packages;

(2) The licensee has established procedures for
opening and closing packages in which radioactive material is transported to
provide safety and to assure that, prior to the delivery to a carrier for
transport, each package is properly closed for transport; and

(3) Prior to delivery of a package to a carrier
for transport, the licensee shall assure that any special instructions needed
to safely open the package are sent to, or have been available to the
consignee.

(b) For the purpose of this Rule, a licensee who transports
his own licensed material as a private carrier is considered to have delivered
the material to a carrier for transport.

(c) In addition to the requirements of Paragraphs (a) and
(b) of this Rule, prior to the transport of any nuclear waste, as defined in
Part (d)(2)(A) of Rule .0316 of this Section, outside the confines of the
licensee's facility or other place of use or storage, or prior to the delivery
of any nuclear waste to a carrier for transport, each licensee shall provide
advance notification of such transport to the governor's designee of each state
through which the waste will be transported.

(d) Each advance notification required by Paragraph (c) of
this Rule shall contain the following information:

(1) the name, address, and telephone number of
the shipper, carrier and receiver of the shipment;

(2) a description of the nuclear waste
contained in the shipment as required by the regulations of the U.S. Department
of Transportation in 49 CFR 172.202 and 172.203(d);

(3) the point of origin of the shipment and the
seven‑day period during which departure of the shipment is estimated to
occur;

(4) the seven‑day period during which
arrival of the shipment at state boundaries is estimated to occur;

(5) the destination of the shipment, and the
seven‑day period during which arrival of the shipment is estimated to
occur; and

(6) a point of contact with a telephone number
for current shipment information.

(e) The notification required by Paragraph (c) of this Rule
shall be made in writing to the office of each appropriate governor or
governor's designee. A notification delivered by mail must be postmarked at
least seven days before the beginning of the seven‑day period during
which departure of the shipment is estimated to occur. A notification
delivered by messenger must reach the office of the governor or governor's
designee at least four days before the beginning of the seven‑day period
during which departure of the shipment is estimated to occur. A copy of the
notification shall be retained by the licensee for one year.

(f) The licensee shall notify each appropriate governor or
governor's designee of any changes to schedule information provided pursuant to
Paragraph (c) of this Rule. Such notification shall be by telephone to a
responsible individual in the office of the governor or governor's designee of
the appropriate state or states. The licensee shall maintain for one year a
record of the name of the individual contacted.

(g) Each licensee who cancels a nuclear waste shipment for
which advance notification has been sent shall send a cancellation notice to
the governor or governor's designee of the appropriate state or states. A copy
of the notice shall be retained by the licensee for one year.

(h) A list of governors or governors' designees for other
states is available from the agency by contacting the North Carolina Division
of Radiation Protection, P.O. Box 27687, Raleigh, North Carolina 27611‑7687,
Phone No. 919/571-4141 or facsimile number 919/571-4148. For the notification
required in Paragraphs (c) through (g) of this Rule in North Carolina:

(a) In addition to the requirements set forth in Rule .0317
of this Section, an application for a license authorizing construction and
operation of an incinerator as part of a radioactive waste processing facility
as defined in Rule .0104 of this Chapter shall include an environmental
assessment that addresses the following topics:

(1) description of the applicant:

(A) the company or corporate structure with the names,
addresses and titles of officers;

(B) present products and activities;

(C) prior experience in the use, processing and disposal
of radioactive material;

(A) structure of facility organization showing line
configuration of the radiation safety officer;

(B) qualifications of management, supervisory and safety
personnel;

(C) staff training program;

(6) description of waste:

(A) general chemical, physical and radiological
properties;

(B) maximum quantity of each radionuclide to be
incinerated per year;

(C) maximum quantity of each radionuclide to be stored
on‑site at any one time;

(D) maximum quantity of each toxic or hazardous
constituent of the waste to be incinerated per year;

(E) maximum quantity of each toxic or hazardous
constituent of the waste to be stored on‑site at any one time;

(F) acceptance and rejection criteria for waste to be
received for incineration;

(7) treatment of waste to be shipped off‑site:

(A) classification;

(B) immobilization;

(C) packaging;

(D) storage;

(E) shipment;

(F) disposal;

(G) processing and disposal of ash;

(8) prelicensing and operational public
information program:

(A) state and local government;

(B) media and public;

(9) plan for maintaining radiation exposures
and releases of radioactivity as low as reasonably achievable (ALARA):

(A) procedures, systems and criteria to maintain whole
body, thyroid, and other organ radiation doses of the off‑site public as
low as reasonably achievable below the limits stated in Section .1600 of this
Chapter;

(B) procedures, systems and criteria to maintain whole
body, thyroid, and other organ radiation doses of on‑site personnel as
low as reasonably achievable below the limits established in Section .1600 of
this Chapter;

(10) off‑site impact assessment for routine
operation:

(A) maximum quantity and concentration of each
radionuclide and toxic or hazardous constituent of the waste released annually
to the air, to the water and to the soil;

(B) maximum radiation doses to off‑site
populations to include dose to the nearest resident, a description of
computational models, sample computations and a summary of any previous
experience;

(E) if available, copies of most current emergency
response plans submitted to the U.S. Nuclear Regulatory Commission or an
agreement state;

(15) decontamination and decommissioning:

(A) schedule;

(B) procedure;

(C) radioactive waste disposal plan.

(b) The applicant shall submit to the agency ten copies of
the license application, environmental assessment, and other information
required in Paragraph (a) of this Rule and Rule .0317 of this Section.

(a) Subject to the limitations in Paragraphs (b) and (c) of
this Rule, any licensee is exempt from the provisions of G.S. 104E‑6.1,
G.S. 104E‑10.1, G.S. 104E-20(b), G.S. 104E-25, and G.S. 104E-26 with
respect to the following waste management practices:

(1) storage of waste incidental to transfer to
a licensed low‑level radioactive waste facility authorized to receive
such waste;

(2) storage of waste to allow for total decay
of contained radioactive material prior to disposal as nonradioactive waste;

(3) storage of waste to allow for partial decay
of contained radioactive material prior to disposal, incineration or other
treatment; or

(4) compaction, incineration, treatment,
packaging or disposal of waste as provided in the rules in Section .1600 of
this Chapter.

(b) Except as provided in Paragraph (c) of this Rule, the
exemptions in Paragraph (a) of this Rule shall apply only to a licensee:

(1) who possesses and uses radioactive material
pursuant to specific licenses issued by the agency and only to management by
the licensee of waste generated incidental to such possession and use;

(2) who is determined by the agency to be
using sound waste management practices;

(3) who is determined by the agency to be
managing such low volumes or activity of waste that such exemptions will not
endanger the public health or safety or the environment; and

(4) whose combined waste management activities
do not cause a radiation dose to the off‑site public in excess of the
limits stated in Rule .1223 of this Chapter.

(c) The exemptions in Paragraph (a) of this Rule shall also
apply to on‑site disposal of waste by persons who generate waste pursuant
to a license issued by the U.S. Nuclear Regulatory Commission, provided that:

(1) the U.S. Nuclear Regulatory Commission
determines that such on‑site disposal is subject to regulation by the
agency;

(2) such persons satisfy the requirements in
Subparagraphs (b)(2) and (b)(3) of this Rule;

(3) such persons do not receive waste,
generated by others or generated at other sites for the purpose of disposal;

(4) such persons shall limit off‑site
dose to the public, resulting from all activities authorized by the agency and
the U.S. Nuclear Regulatory Commission, to the limits stated in Rule .1223 of
this Chapter or as prescribed by the U.S. Nuclear Regulatory Commission, 10 CFR
Part 50 for U.S. Nuclear Regulatory Commission regulated activities, whichever
is more restrictive;

(5) such persons apply for and receive a
specific radioactive material license, issued by the agency pursuant to the
rules in this Section, which authorizes such disposal pursuant to Rule .1628 of
this Chapter; and

(6) such persons provide notification to the
agency prior to each disposal made pursuant to any radioactive material license
described in Subparagraph (c)(5) of this Rule.

History Note: Filed as a Temporary Amendment Eff.
November 22, 1995, for a period of 180 days or until

(a) Provided that mobile nuclear medicine services shall be
limited to clients who do not have a specific radioactive material license for
the same services, unless the client's specific license specifically authorizes
the use of such mobile services, the agency will license a mobile nuclear
medicine service for the following services:

(1) uptake, dilution and excretion;

(2) imaging and localization;

(3) sealed sources for diagnosis; and

(4) certain in vitro clinical or laboratory
testing.

(b) The mobile nuclear medicine service licensee shall:

(1) obtain a letter signed by the management of
each client for which services are rendered that authorizes the licensee to use
radioactive material at the client's address of use;

(2) retain the letter for two years after the
last provision of service;

(3) not order radioactive material to be
delivered directly from the manufacturer or distributor to the client's address
of use;

(4) transport to each address of use only
syringes or vials containing prepared radiopharmaceuticals or
radiopharmaceuticals that are intended for reconstitution of
radiopharmaceuticals kits;

(5) bring into each address of use of all
radioactive material to be used and before leaving, remove all unused
radioactive material and all associated waste;

(6) secure or keep under constant surveillance
and immediate control all radioactive material when in transit or at an address
of use;

(7) check survey instruments, dose calibrators
and all other transported equipment for proper function before medical use at
each address of use;

(8) carry a radiation detection survey meter in
each vehicle that is being used to transport radioactive material and, before
leaving a client address of use, survey all radiopharmaceutical areas of use
with a radiation detection survey meter to ensure that all radiopharmaceuticals
and all associated waste have been removed; and

(9) retain a record of each survey required in
Subparagraph (b)(8) of this Rule for two years, where such records shall
include:

(A) the date of the survey,

(B) a plan of each area that was surveyed,

(C) the measured dose rate at several points in each
area of use expressed in millirem per hour,

(D) the instrument used to make the survey; and

(E) the initials of the individual who performed the
survey.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the

(a) Each application to possess radioactive materials in
unsealed form, on foils or plated sources, or sealed in glass in excess of the
quantities in the table in Subparagraph (e)(1) of this Rule must contain
either:

(1) an evaluation showing that the maximum dose
to a person off-site due to a release of radioactive materials would not exceed
one rem effective dose equivalent or five rems to the thyroid; or

(2) an emergency plan for responding to a
release of radioactive material.

(b) The following factors shall be used to support an
evaluation submitted under Subparagraph (a)(1) of this Rule:

(1) the radioactive material is physically
separated so that only a portion could be involved in an accident;

(2) all or part of the radioactive material is
not subject to release during an accident because of the way it is stored or
packaged;

(3) the release fraction in the respirable size
range would be lower than the release fraction shown in Subparagraph (e)(1) of
this Rule due to the chemical or physical form of the material;

(4) the solubility of the radioactive material
would reduce the dose received;

(5) the facility design or engineered safety
features in the facility would cause the release fraction to be lower than
shown in Subparagraph (e)(1) of this Rule; and

(6) the operating restrictions or procedures
would prevent a release fraction as large as that shown in Subparagraph (e)(1)
of this Rule; or

(7) the factors appropriate for the specific
facility.

(c) An emergency plan for responding to a release of
radioactive material submitted under Subparagraph (a)(2) of this Rule must
include the following information:

(1) a description of the licensee's facility
and potentially impacted area;

(2) the identification of each type of
radioactive materials accident for which protective actions may be needed;

(3) the classification system for classifying
accidents as alerts or site area emergencies;

(4) the identification of the means of
detecting each type of accident in a timely manner quickly enough to mitigate
off-site consequences;

(5) a description of the means and equipment
for mitigating the consequences of each type of accident, including those
provided to protect workers on-site, and a description of the program for
maintaining the equipment;

(6) a description of the methods and equipment
to assess releases of radioactive materials;

(7) a description of the responsibilities of
licensee personnel, should an accident occur, including identification of
personnel responsible for notifying off-site response organizations and the
agency, and responsibilities for developing, maintaining, and updating the
plan;

(8) a description of notification and
coordination, to include a commitment to and a brief description of the means
to notify off-site response organizations and request off-site assistance,
including medical assistance for the treatment of contaminated injured on-site
workers when needed, provided that:

(A) a control point is established;

(B) the notification and coordination is planned so that
unavailability of some personnel, parts of the facility, and some equipment
will not prevent the notification and coordination;

(C) the licensee commits to notify the agency after
notification of the appropriate off-site response organizations, within one
hour after the licensee declares an emergency; and

(D) the reporting requirements in this Subparagraph do
not substitute for or relieve the licensee from responsibility for complying
with the requirements in the Emergency Planning and Community Right-to-Know Act
of 1986, Title III, Public Law 99-499 or other State or federal reporting
requirements;

(9) description of the types of information on
facility status, radioactive releases, and recommended protective actions, if
necessary, to be given to off-site response organizations and to the agency;

(10) description of the frequency, performance
objectives and plans for the training that the licensee will provide to workers
on how to respond to an emergency, including any instructions and orientation
tours the licensee offers to fire, police, medical and other emergency
personnel, where such training shall:

(B) prepare site personnel for their responsibilities in
the event of accident scenarios postulated as most probable for the specific
site, including the use of team training for such scenarios;

(11) description of the means of restoring the
facility to a safe condition after an accident;

(12) description of provisions for conducting
quarterly communications checks with off-site response organizations and
biennial on-site exercises to test response to simulated emergencies where such
provisions meet the following requirements:

(A) quarterly communications checks with off-site
response organizations include the check and update of all necessary telephone
numbers;

(B) while participation of off-site response
organizations in biennial exercises is not required, the licensee shall invite
off-site response organizations to participate in the biennial exercises;

(C) accident scenarios for biennial exercises are not known
to most exercise participants;

(D) critique of each exercise using individuals who do not
have direct implementation responsibility for the plan. Critiques of exercises
evaluate the appropriateness of the plan, emergency procedures, facilities,
equipment, training of personnel, and overall effectiveness of the response;
and

(E) deficiencies found by the critiques in Part
(c)(12)(D) of this Rule are corrected; and

(13) certification that the applicant has met its
responsibilities under the Emergency Planning and Community Right-to-Know Act
of 1986, Title III, Public Law 99-499, if applicable to the applicant's
activities at the proposed place of use of the radioactive material.

(d) The licensee shall submit the emergency plan to allow
the off-site response organizations expected to respond in case of an accident
60 days to comment on the licensee's emergency plan before submitting the plan
to the agency. The licensee shall provide any comments received within the 60
day comment period to the agency with the emergency plan.

(e) Quantities of radioactive material requiring an
emergency plan for responding to a release as used in this Rule and
instructions for use are:

TABLE

RADIOACTIVE MATERIAL RELEASE QUANTITY

FRACTION (CURIES)

Actinium-228 0.001 4,000

Americium-241 .001 2

Americium-242 .001 2

Americium-243 .001 2

Antimony-124 .01 4,000

Antimony-126 .01 6,000

Barium-133 .01 10,000

Barium-140 .01 30,000

Bismuth-207 .01 5,000

Bismuth-210 .01 600

Cadmium-109 .01 1,000

Cadmium-113 .01 80

Calcium-45 .01 20,000

Californium‑252 .001 9
(20 mg)

Carbon-14 (NON CO2) .01 50,000

Cerium-141 .01 10,000

Cerium-144 .01 300

Cesium-134 .01 2,000

Cesium-137 .01 3,000

Chlorine-36 .5 100

Chromium-51 .01 300,000

Cobalt-60 .001 5,000

Copper-64 .01 200,000

Curium-242 .001 60

Curium-243 .001 3

Curium-244 .001 4

Curium-245 .001 2

Europium-152 .01 500

Europium-154 .01 400

Europium-155 .01 3,000

Germanium-68 .01 2,000

Gadolinium-153 .01 5,000

Gold-198 .01 30,000

Hafnium-172 .01 400

Hafnium-181 .01 7,000

Holmium-166m .01 100

Hydrogen-3 .5 20,000

Iodine-125 .5 10

Iodine-131 .5 10

Iodine-114m .01 1,000

Iridium-192 .001 40,000

Iron-55 .01 40,000

Iron-59 .01 7,000

Krypton-85 1.0 6,000,000

Lead-210 .01 8

Manganese-56 .01 60,000

Mercury-203 .01 10,000

Molybdenum-99 .01 30,000

Neptunium-237 .001 2

Nickel-63 .01 20,000

Niobium-94 .01 300

Phosphorus-32 .5 100

Phosphorus-33 .5 1,000

Polonium-210 .01 10

Potassium-42 .01 9,000

Promethium-145 .01 4,000

Promethium-147 .01 4,000

Radium-226 .001 100

Ruthenium-106 .01 200

Samarium-151 .01 4,000

Scandium-46 .01 3,000

Selenium-75 .01 10,000

Silver-110m .01 1,000

Sodium-22 .01 9,000

Sodium-24 .01 10,000

Strontium-89 .01 3,000

Strontium-90 .01 90

Sulfur-35 .5 900

Technetium-99 .01 10,000

Technetium-99m .01 400,000

Tellurium-127m .01 5,000

Tellurium-129m .01 5,000

Terbium-160 .01 4,000

Thulium-170 .01 4,000

Tin-113 .01 10,000

Tin-123 .01 3,000

Tin-126 .01 1,000

Titanium-44 .01 100

Vanadium-48 .01 7,000

Xenon-133 1.0 900,000

Yttrium-91 .01 2,000

Zinc-65 .01 5,000

Zirconium-93 .01 400

Zirconium-95 .01 5,000

Any other beta-gamma emitter .01 10,000

Mixed fission products .01 1,000

Mixed corrosion products .01 10,000

Contaminated equipment beta-gamma .001 10,000

Irradiated material, any form

other than solid noncombustible .01 1,000

Irradiated material, solid

noncombustible .001 10,000

Mixed radioactive waste

Beta-gamma .01 1,000

Packaged mixed waste, beta-gamma .001 10,000

Any other alpha emitter .001 2

Contaminated equipment, alpha .0001 20

Packaged waste, alpha .0001 20

(f) For combinations of radioactive materials, an emergency
plan is required if the sum of the ratios of the quantity of each radioactive material
authorized to the quantity listed for that material in the table in Paragraph
(e) of this Rule exceeds one.

(g) Waste packaged in Type B containers, as defined in 10
CFR Part 71.4, does not require an emergency plan.

(a) Applications for a new license filed with the agency
under Rule .0317 of this Section, and applications for the renewal of a license
filed with the agency under Rule .0340 of this Section, shall include an
evaluation of the need for financial assurance based upon the quantity of
radioactive material requested in the application.

(b) Applications for amendment of a license filed with the
agency under Rule .0341 of this Section, changing the quantity of radioactive
material authorized for possession by a licensee, shall include an evaluation
of the need for financial assurance based upon the quantity of radioactive
material that shall be authorized by the amended license.

(c) Evaluation of the need for financial assurance shall be
performed by the applicant based upon the type of application listed in
Paragraph (a) or (b) of this Rule, using one or more the methods shown in
Paragraph (d) of this Rule.

(d) Applicants shall require financial assurance to possess
the following types and quantities of radioactive material:

(1) byproduct material in the quantities shown
in 10 CFR 30.35(a) or (b);

(2) source material in the quantities shown in
10 CFR 40.36(a) or (b); and

(3) special nuclear material in the quantities
shown in 10 CFR 70.25(a)(2) or (b).

(e) Applicants requiring financial assurance shall:

(1) comply with the provisions of 10 CFR
30.35(c) for the possession of byproduct material;

(2) comply with the provisions of 10 CFR
40.36(c) for the possession of source material; and

(3) comply with the provisions of 10 CFR
70.25(c) for the possession of special nuclear material.

(f) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(b) Licensees or applicants for a radioactive materials
license authorizing the use of any combination of radioactive material listed
in Paragraph (a) of this Rule shall provide for financial assurance in
accordance with the evaluation performed for Rule .0353(c) of this Section.

(c) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Licensees or applicants for a radioactive materials
license requiring financial assurance under Rule .0353 of this Section may
self-guarantee funds, or provide a guarantee of funds by their parent company
for decommissioning funding in accordance with the provisions of Rule .0354 of
this Section, except that:

(1) parent companies guaranteeing funds for
decommissioning shall have a tangible net worth of at least ten million dollars
($10,000,000) to meet the asset requirement set forth in Section II, Paragraphs
A.1(iii) or A.2(iii), of Appendix A to 10 CFR Part 30;

(2) licensees self-guaranteeing funds for
decommissioning who issue bonds, and whose bonds meet the bond rating
requirements of Section II, Paragraph A.(3) of Appendix C to 10 CFR Part 30
shall have a tangible net worth of at least ten million dollars ($10,000,000),
and at least six times the amount of decommissioning funds being assured by the
self-guarantee to meet the asset requirements set forth in Section II,
Paragraph A.(2) and A.(3) of Appendix C to 10 CFR Part 30;

(3) licensees self-guaranteeing funds for
decommissioning who do not issue bonds, or whose bonds do not meet the bond
rating requirements of Section II, Paragraph A.(3) of Appendix C to 10 CFR Part
30, shall have a tangible net worth of at least ten million dollars
($10,000,000), and at least six times the amount of decommissioning funds being
assured by the self-guarantee to meet the asset requirements set forth in
Section II, Paragraph A.(1) and A.(2) of Appendix D to 10 CFR Part 30;

(5) licensees self-guaranteeing funds for
decommissioning who are nonprofit privately funded, or nonprofit semi-privately
funded colleges, or universities who do not issue bonds, or whose bonds do not
meet the bond rating requirements of Section II, Paragraph A.(1) of Appendix E
to Part 30 shall have an unrestricted endowment consisting of assets worth of
at least ten million dollars ($10,000,000), and at least six times the amount
of decommissioning funds being assured by the self-guarantee to meet the asset
requirements set forth in Section II, Paragraph A.(2) of Appendix E to 10 CFR
Part 30; or

(6) licensees self-guaranteeing funds for
decommissioning who are nonprofit privately funded, or nonprofit semi-privately
funded hospitals who do not issue bonds, or whose bonds do not meet the bond
rating requirements of Section II, Paragraph B.(1) of Appendix E to 10 CFR Part
30 shall have a tangible net worth of at least ten million dollars
($10,000,000), and at least six times the amount of decommissioning funds being
assured by the self-guarantee to meet the asset requirements set forth in
Section II, Paragraph B.(2) of Appendix E to 10 CFR Part 30.

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) For any administration requiring a written directive,
the licensee shall develop, implement, and maintain written procedures to
provide that:

(1) The patient or human research subject's
identity is verified before each administration; and

(2) Each administration is in accordance with
the written directive.

(b) The procedures required by Paragraph (a) of this Rule
must address the following items that are applicable to the licensee's use of
radioactive material:

(1) Verify the identity of the patient or human
research subject;

(2) Verify that the administration is in
accordance with the treatment plan, if applicable, and the written directive;

(3) Check both manual and computer-generated
dose calculations; and

(4) Verify that any computer-generated dose
calculations are correctly transferred into the consoles of therapeutic medical
units.

(c) A licensee shall retain a copy of the procedures
required under Paragraph (a) until the agency terminates the pertinent license.

(d) If, because of the emergent nature of the patient's
condition, a delay in order to provide a written directive would jeopardize the
patient's health, an oral directive is acceptable. The information contained in
the oral directive shall be documented as soon as possible in writing in the
patient's record. A written directive must be prepared within 48 hours of the
oral directive.

(e) A revision to an existing written directive may be
made:

(1) if the revision is dated and signed by an
authorized user before the administration of the dosage of unsealed radioactive
material, the brachytherapy dose, the gamma stereotactic radiosurgery dose, the
teletherapy dose, or the next fractional dose, or

(2) if, because of the patient's condition, a
delay in order to provide a written revision to an existing written directive
would jeopardize the patient's health, an oral revision to an existing written
directive is acceptable. The oral revision must be documented as soon as
possible in the patient's record. A revised written directive must be signed by
the authorized user within 48 hours of the oral revision.

(f) The licensee shall retain a record of the written
directive and any revisions to the written directive for three years.

History Note: Authority G.S. 104E-7; 104E-10(b);

Temporary Adoption Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

(a) All reports required by this Rule shall be made to the
agency in accordance with Rule .0111 of this Chapter.

(b) Reports of incidents involving exposure, or incidents
threatening to cause exposure to radiation in excess of the annual occupational
limits of Rule .1604 of this Chapter, shall be made to the agency in accordance
with the provisions of 10 CFR 20.2202.

(c) Reports of an event that prevents taking protective
actions to avoid exposure to radiation or to radioactive material that could
cause exposures in excess of the regulatory limits of this Chapter shall be
made to the agency in accordance with the provisions of:

(1) 10 CFR 30.50 for licensees authorized for
the possession and use of byproduct material;

(2) 10 CFR 40.60 for licensees authorized for
the possession and use of source material; and

(3) 10 CFR 70.50 of this Chapter for licensees
authorized for the possession and use of special nuclear material.

(d) Reports of exposure to radiation exceeding the exposure
limits in Section .1600 of this Chapter, or to concentrations of radioactive
material in any restricted or unrestricted area in excess of licensed or
regulatory limits of 10 CFR 20.2203(a)(3) shall be made to the agency in
accordance with 10 CFR 20.2203.

(e) Reports of incidents or events occurring at irradiation
facilities licensed under the provisions of 10 CFR 36.1(b) shall be made to the
agency in accordance with 10 CFR 36.83.

(f) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

History Note: Authority G.S. 104E-7(a)(2); 104E-10(b);

Temporary Adoption Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

(a) A licensee may authorize the release from its control
any individual who has been administered radiopharmaceuticals or permanent
implants containing radioactive material if the total effective dose equivalent
to any other individual from exposure to the released individual is not likely
to exceed 500 millirem (5 mSv).

(b) The licensee shall provide the released individual, or
the individual's parent or guardian, with oral and written instructions, on
actions recommended to maintain doses to other individuals as low as reasonably
achievable if the total effective dose equivalent to any other individual is
likely to exceed 100 millirem (1 mSv). If the dose to a breast-feeding infant
or child could exceed 100 millirem (1 mSv) if there is no interruption of
breast-feeding, the instructions shall include:

(1) Guidance on the interruption or discontinuation
of breast-feeding; and

(2) Information on the consequences of failure
to follow the guidance.

(c) The licensee shall maintain a record of the basis for
authorizing the release of an individual for three years after the date of
release, if the total effective dose equivalent is calculated by:

(1) Using the retained activity rather than the
activity administered;

(2) Using an occupancy factor less than 0.25 at
one meter;

(3) Using the biological or effective half-life;
or

(4) Considering the shielding by tissue.

(d) The licensee shall maintain a record for three years
after the date of the release that instructions were provided to a
breast-feeding woman if the radiation dose to the infant or child from
continued breast-feeding could result in a total effective dose equivalent
exceeding 100 millirem (1 mSv).

(a) Licensees shall comply with the provisions of 10 CFR
35.63, except that dosage determination shall be made by direct measurement for
all unsealed photon-emitting radioactive drugs prior to administration to any
person. Licensees shall ensure that instruments used to measure dosages under
this Rule are calibrated in accordance with the provisions of 10 CFR 35.60.

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) A licensee shall survey with a radiation detection
survey instrument at the end of each day of use all areas where
radiopharmaceuticals are routinely prepared for use or administered.

(b) A licensee shall conduct the survey required by
Paragraph (a) of this Rule so as to be able to detect dose rates as low as 0.1
millirem (1 microsievert) per hour.

(c) A licensee shall establish radiation dose rate trigger
levels for the surveys required by Paragraph (a) of this Rule. A licensee
shall require the individual performing the survey to promptly notify the
Radiation Safety Officer if a dose rate exceeds a trigger level.

(d) A licensee shall retain a record of the survey required
by this Rule for three years. The record shall include:

(1) the date of the survey;

(2) a plan of each area surveyed;

(3) the trigger level established for each
area;

(4) the detected dose rate at several points in
each area surveyed expressed in millirem (or microsievert) per hour;

(5) the instrument used to make the survey; and

(6) the initials of the individual who
performed the survey.

(e) Any licensee authorized by the rules of this Chapter to
manufacture, produce, acquire, receive, possess, use or transfer radioactive
material for medical use shall have in its possession a calibrated portable
radiation survey instrument capable of detecting dose rates over the range of
0.1 millirem per hour (1 microsievert per hour) to 100 millirem per hour (.01
millisievert per hour), and a portable radiation survey instrument capable of
measuring dose rates over the range of one millirem per hour (.01 millisievert
per hour) to 1,000 millirem per hour (10 millisievert per hour). A licensee
shall calibrate the survey instruments used to show compliance with this
Section before first use, annually, and following repair. The licensee shall:

(1) calibrate all scales with readings up to
1,000 millirem (10 millisievert) per hour with a radiation source;

(2) calibrate two separated readings on each
scale that must be calibrated; and

(3) conspicuously note on the instrument the
apparent exposure rate from a dedicated check source as determined at the time
of calibration, and the date of calibration.

(f) When calibrating a survey instrument, the licensee
shall consider a point as calibrated if the indicated exposure rate differs
from the calculated exposure rate by not more than 20 percent.

(g) A licensee shall check each survey instrument for
proper operation with the dedicated check source each day of use. A licensee is
not required to keep records of these checks.

(h) A licensee shall retain a record of each survey
instrument calibration for three years. The record must include:

(1) a description of the calibration procedure;
and

(2) the date of the calibration, a description
of the source used and the certified exposure rates from the source, and the
rates indicated by the instrument being calibrated, the correction factors
deduced from the calibration data, and the identity of the individual who
performed the calibration.

(a) A licensee may use any unsealed radioactive material
prepared for use for uptake, dilution, or excretion studies, imaging and
localization studies, and use requiring a written directive as set forth in
Rule .0104 of this Chapter that is:

(1) Obtained from a manufacturer or preparer
licensed under 10 CFR 32.72 or equivalent Agreement State requirements;

(B) A physician is an authorized user identified on a
North Carolina Radioactive Materials License, an Agreement State Radioactive Materials
License, or a license issued by the U.S. Nuclear Regulatory Commission or who
meets the requirements in 15A NCAC 11 .0318(c); or

(C) An individual under the supervision, as specified in
Rule .0318 of this Section, of the authorized nuclear pharmacist in Part
(a)(3)(A) of this Rule or the physician who is an authorized user in Part
(a)(3)(B) of this Rule;

(4) Obtained from and prepared by an NRC or
Agreement State licensee for use in research in accordance with a Radioactive
Drug Research Committee-approved protocol or an Investigational New Drug (IND)
protocol accepted by the FDA; or

(5) Prepared by the licensee for use in
research in accordance with a Radioactive Drug Research Committee-approved
protocol or an Investigational New Drug (IND) protocol accepted by the FDA.

(b) A licensee shall not administer to humans a
radiopharmaceutical that contains;

(1) more than 0.15 microcurie (0.15
kilobecquerel) of molybdenum-99 per millicurie (megabecquerel) of
technetium-99m; or

(2) more than 0.02 microcurie (0.02
kilobecquerel) of strontium-82 per millicurie (megabecquerel) of rubidium-82
chloride, or 0.2 microcurie (0.2 kilobecquerel) of strontium-85 per millicurie
(megabecquerel) of rubidium-82 chloride.

(c) A licensee that uses molybdenum-99/technetium-99m
generators for preparing a technetium-99 radiopharmaceutical shall measure the
molybdenum-99 concentration in the first eluate after receipt of a generator to
demonstrate compliance with Paragraph (b) of this Rule.

(d) A licensee that uses strontium-82/rubidium-82
generators for preparing a rubidium-82 radiopharmaceutical shall measure the
concentrations of strontium-82 and strontium-85 before the first patient use of
the day to demonstrate compliance with Paragraph (b) of this Rule.

(e) A licensee that must measure molybdenum-99 or
strontium-82 and strontium-85 concentration shall retain a record of each
measurement for three years. The record shall include:

(1) for each measured elution of
technetium-99m: the ratio of the measures expressed as microcuries of
molybdenum-99 per millicurie of technetium-99m (or kilobecquerels of
molybdenum-99 per megabecquerel of technetium-99m);

(2) for each measured elution of rubidium-82:
the ratio of the measures expressed as microcuries of strontium-82 and strontium-85
per millicurie of rubidium-82 (or kilobecquerel strontium-82 and strontium-85
per megabecquerel rubidium-82); and

(a) A licensee may hold radioactive material with a
physical half-life of less than 275 days for decay-in-storage before disposal
in ordinary trash and is exempt from the requirements of Rule .1628 of this
Chapter if the licensee:

(1) holds radioactive material for decay a
minimum of 10 half-lives;

(2) monitors radioactive material at the container
surface before disposal as ordinary trash and determines that its radioactivity
cannot be distinguished from the background radiation level with a radiation
detection survey meter capable of detecting a dose rate of 0.1 millirem (1
microsievert) per hour and with no interposed shielding; and

(3) removes or obliterates all radiation
labels.

(b) A licensee shall retain a record of each disposal
permitted under Paragraph (a) of this Rule for three years. The record shall include:

10A NCAC 15 .0363 provisions for the protection of human
research subjects

(a) A licensee may conduct research involving human
research subjects only if it uses the radioactive materials specified on its
license for the uses authorized on its license.

(b) If the research is conducted, funded, supported, or
regulated by a Federal agency that has implemented the Federal Policy for the
Protection of Human Research Subjects (Federal Policy), the licensee shall,
before conducting research:

(1) Obtain review and approval of the research
from an "Institutional Review Board" as defined and prescribed in the
Federal Policy; and

(2) Obtain "informed consent" as
defined and described in the Federal Policy, from the human research subject.

(c) If the research will not be conducted, funded,
supported, or regulated by a Federal agency that has implemented the Federal
Policy, the licensee shall, before conducting research, apply for and receive a
specific amendment to its medical use license. The amendment request must
include a written commitment that the licensee will, before conducting
research:

(1) Obtain review and approval of the research
from an "Institutional Review Board" as defined and described in the
Federal Policy; and

(2) Obtain "informed consent," as described
in the Federal Policy, from the human research subject.

(d) Nothing in this Rule relieves licensees from complying
with the other requirements in this Chapter or with any other applicable Rules
and Laws in the State of North Carolina.

(a) A licensee shall report any event, except for an event
that results from patient intervention, in which the administration of
radioactive material or radiation from radioactive material results in:

(1) A dose that differs from the prescribed
dose or dose that would have resulted from the prescribed dosage by more than 5
rem (0.05 Sievert (Sv)) effective dose equivalent, 50 rem (0.5 Sv) to an organ
or tissue, or 50 rem (0.5 Sv) shallow dose equivalent to the skin; and

(A) The total dose delivered differs from the prescribed
dose by 20 percent or more;

(B) The total dosage delivered differs from the
prescribed dosage by 20 percent or more or falls outside the prescribed dosage
range; or

(C) The fractionated dose delivered differs from the
prescribed dose, for a single fraction, by 50 percent or more.

(2) A dose that exceeds 5 rem (0.05 Sv)
effective dose equivalent, 50 rem (0.5 Sv) to an organ or tissue, or 50 rem
(0.5 Sv) shallow dose equivalent to the skin from any of the following:

(B) An administration of a radioactive drug containing
radioactive material by the wrong route of administration;

(C) An administration of a dose or dosage to a wrong
individual or human research subject;

(D) An administration of a dose or dosage delivered by
the wrong mode of treatment; or

(E) A leaking sealed source.

(3) A dose to the skin or an organ or tissue
other than the treatment site that exceeds by 50 rem (0.5 Sv) and 50 percent or
more of the dose expected from the administration defined in the written
directive (excluding, for permanent implants, seeds that were implanted in the
correct site but migrated outside the treatment site).

(b) A licenses shall report any event resulting from
intervention of a patient or human research subject in which the administration
of radioactive material or radiation from radioactive material results or will
result in an unintended permanent functional damage to an organ or a
physiological system, as determined by a physician.

(c) The licensee shall notify by telephone the agency no
later than the next calendar day after discovery of the medical event.

(d) The licensee shall submit a written report to the
agency at the address listed in Rule .0111 of this Chapter within 15 days of
the discovery of the medical event. The written report must include:

(1) The licensee's name;

(2) The name of the prescribing physician;

(3) A brief description of the event;

(4) Why the event occurred;

(5) The effect, if any, on the individual(s)
who received the administration;

(6) What actions, if any, have been taken or
are planned to prevent recurrence; and

(7) Certification that the licensee notified
the individual (or the individual's responsible relative or guardian) and if
not, why not.

The report may not contain the individual's name or any
other information that could lead to identification of the individual.

(e) The licensee shall provide notification of the event to
the referring physician and also notify the individual who is the subject of
the medical event no later than 24 hours after its discovery unless the
referring physician personally informs the licensee either that he or she will
inform the individual or that based on medical judgment, telling the individual
would be harmful. The licensee is not required to notify the individual
without first consulting the referring physician. If the referring physician
or the affected individual cannot be reached within 24 hours, the licensee
shall notify the individual as soon as possible thereafter. The licensee may
not delay any appropriate medical care for the individual, including any
necessary remedial care as a result of the medical event, because of any delay
in notification. To meet the requirements of this Paragraph, the notification
of the individual who is the subject of the medical event may be made instead
to that individual's responsible relative or guardian. If a verbal
notification is made, the licensee shall inform the individual, or responsible
relative or guardian, that a written description of the event can be obtained
from the licensee upon request. The licensee shall provide such a written
description if requested.

(f) Aside from the notification requirement, nothing in
this Section affects any rights or duties of licensees and physicians in
relation to each other, to individuals affected by the medical event, or to
that individual's responsible relatives or guardians.

(g) A licensee shall:

(1) Annotate a copy of the report provided to
the agency with the:

(A) Name of the individual who is the subject of the
event; and

(B) Social security number or other identification
number, if one has been assigned, of the individual who is the subject of the
medical event; and

(2) Provide a copy of the annotated report to
the referring physician if other than the licensee, no later than 15 days after
the discovery of the event.

10A NCAC 15 .0365 REPORT AND NOTIFICATION OF A DOSE TO
AN EMBRYO/FETUS OR A NURSING CHILD

(a) A licensee shall report any dose to an embryo/fetus
that is greater than 5 rem (50 mSv) dose equivalent that is a result of an
administration of radioactive material or radiation from radioactive material
to a pregnant individual unless the dose to the embryo/fetus was specifically
approved, in advance, by that authorized user.

(b) A licensee shall report any dose to a nursing child
that is a result of administration of radioactive material to a breast-feeding
individual, that:

(1) Is greater than 5 rem (50 mSv) total
effective dose equivalent; or

(2) Has resulted in unintended permanent
functional damage to an organ or a physiological system of the child, as determined
by a physician.

(c) The licensee shall notify by telephone the agency no
later than the next calendar day after discovery of a dose to the embryo/fetus
or nursing child that requires a report in Paragraphs (a) or (b) of this Rule.

(d) The licensee shall submit a written report to the
agency at the address listed in Rule .0111 of this Chapter within 15 days after
discovery of a dose to the embryo/fetus or nursing child that requires a report
in Paragraphs (a) or (b) in this Rule.

(1) The written report must include:

(A) The licensee's name;

(B) The name of the prescribing physician;

(C) A brief description of the event;

(D) Why the event occurred;

(E) The effect, if any, on the embryo/fetus or the
nursing child;

(F) What actions, if any, have been taken or are
planned to prevent recurrence; and

(G) Certification that the licensee notified the
pregnant individual or mother (or the mother's or child's responsible relative
or guardian), and if not, why not.

(2) The report must not contain the individual's
or child's name or any other information that could lead to identification of
the individual or child.

(e) The licensee shall provide notification of the event to
the referring physician and also notify the pregnant individual or mother, both
hereafter referred to as the mother, no later than 24 hours after discovery of
an event that would require reporting under Paragraphs (a) or (b) of this Rule,
unless the referring physician personally informs the licensee either that he
or she will inform the mother or that, based on medical judgment, telling the
mother would be harmful. The licensee is not required to notify the mother
without first consulting with the referring physician. If the referring
physician or mother cannot be reached within 24 hours, the licensee shall make
the appropriate notifications as soon as possible thereafter. The licensee may
not delay any appropriate medical care for the embryo/fetus or for the nursing
child, including any necessary remedial care as a result of the event, because
of any delay in notification. To meet the requirements of this Paragraph, the
notification may be made to the mother's or child's responsible relative or
guardian instead of the mother. If a verbal notification is made, the licensee
shall inform the mother, or the mother's or child's responsible guardian, that
a written description of the event can be obtained from the licensee upon
request, The licensee shall provide such a written description if requested.

(f) A licensee shall:

(1) Annotate a copy of the report provided to
the agency with the:

(A) Name of the pregnant individual or the nursing child
who is the subject of the event; and

(B) Social security number or other identification
number, if one has been assigned, of the pregnant individual or the nursing
child who is the subject of the event; and

(2) Provide a copy of the annotated report to
the referring physician, if other than the licensee, no later than 15 days
after the discovery of the event.

(a) The rules in this Section establish radiation safety
requirements for persons utilizing sources of radiation for industrial
radiography. The requirements of this Section are in addition to and not in
substitution for the other requirements of this Chapter.

(b) The rules in this Section apply to all licensees or
registrants who use sources of radiation for industrial radiography; provided,
however that nothing in this Section shall apply to the use of sources of
radiation in the healing arts.

In addition to terms found in Rule .0104 of this Chapter and
10 CFR 34.3, the following definitions shall apply to this Section. 10 CFR
34.3 is incorporated by reference to include subsequent amendments and
editions, and can be accessed at:
http://www.nrc.gov/reading-rm/doc-collections/cfr/part034/part034-0003.html at
no cost:

(1) "Collimator" means a radiation shield
that is placed on the end of the guide tube or directly onto a radiographic
exposure device to limit the size, shape, and direction of the primary
radiation when the sealed source is cranked into position to make a
radiographic exposure.

(2) "Control device," commonly called a
crank-out, means the control cable, the protective sheath, and control drive
mechanism used to move the sealed source from the shielded position in the
radiographic device or camera to an unshielded position outside the device for
the purpose of making a radiographic exposure.

(3) "Field examination" means a practical
examination.

(4) "Independent certifying organization"
means an independent organization that meets all of the requirements of Rule
.0525 of this Section.

(5) "Periodic training" means instruction provided
at least every 12 months by the licensee or registrant for operators and
individuals subject to the requirements of Rule .1003 of this Chapter on
radiation safety aspects of radiography. The topics shall include the results
of internal inspections, new procedures or equipment, accidents or errors that
have been observed, and opportunities for employees to ask safety questions.

(6) "Projection sheath" means a guide tube.

(7) "Radiation safety officer" means an
individual named by the licensee or registrant who has knowledge of and
responsibility for the overall radiation safety program on behalf of the
licensee or registrant and who meets the requirements of Rule .0510(h) of this
Section.

History Note: Authority G.S. 104E-7; 10 CFR 34.3;

Eff. February 1, 1980;

Amended Eff. January 1, 1994; June 1, 1989;

Temporary Amendment Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

The maximum exposure rate limits for source changers and
storage containers are 200 millirem (2 millisieverts) per hour at any exterior
surface, and 10 millirem (0.1 millisieverts) per hour at one meter from any
exterior surface. The radiation levels specified are with the sealed source in
the shielded position.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(a) Each radiographic exposure device shall have a lock or
outer locked container designed to prevent unauthorized or accidental removal
of the sealed source from its shielded position. The exposure device or its
container shall be kept locked when not under the direct surveillance of a
radiographer or a radiographer's assistant or as otherwise may be authorized in
Rule .0515 of this Section. If the exposure device or container is secured
with a keyed lock, the key shall be removed at all times when the device or
container is not being used. In addition, during radiographic operations, the
sealed source assembly shall be manually secured in the shielded position each
time the sealed source is returned to that position in those devices
manufactured prior to the effective date of this Rule.

(b) Each sealed source storage container and source changer
shall have a lock or outer locked container designed to prevent unauthorized or
accidental removal of the sealed source from its shielded position. Storage
containers and source changers shall be kept locked when containing sealed
sources except when under the direct surveillance of a radiographer or a
radiographer's assistant.

(c) Prior to moving a radiographic exposure device, source
changer or storage container from one temporary jobsite to another, the
licensee shall:

(1) perform a survey to ensure that the sealed
source is in the shielded position;

(1) Locked radiographic exposure devices and
storage containers shall be physically secured to prevent tampering or removal
by unauthorized personnel. The licensee shall store sealed sources in a manner
which will minimize danger from explosion or fire.

(2) The licensee shall lock and physically
secure the transport package containing sealed sources in the transporting
vehicle to prevent accidental loss, tampering or unauthorized removal of the
sealed sources from the vehicle.

(b) Labels:

(1) The licensee shall not use a source changer
or storage container to store sealed sources unless the source changer or the
storage container has securely attached to it a durable, legible, and clearly
visible label. The label shall contain the radiation symbol specified in Rule
.1623 of this Chapter and the wording:

CAUTION (OR
DANGER)

RADIOACTIVE
MATERIAL-- DO NOT HANDLE

NOTIFY CIVIL
AUTHORITIES (OR NAME OF COMPANY)

(2) The licensee shall not transport sealed
sources unless the material is packaged, labeled, marked, and accompanied with
the appropriate shipping papers in accordance with regulations set out in 10
CFR Part 71, including documentation of the Quality Assurance program
requirements outlined in 10 CFR 71.105.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(a) The licensee or registrant shall maintain sufficient
calibrated and operable radiation survey instruments at each temporary jobsite
and at any location where sealed sources or radiation machines are used or
stored to make physical radiation surveys as required by this Rule and Rules
.1613 and .1627 of this Chapter.

(b) Each radiation survey instrument required by Paragraph
(a) of this Rule shall be calibrated:

(1) at intervals not to exceed six months and
after each instrument servicing except for battery change;

(2) at the following points for each
instrument, as applicable:

(A) linear scale instruments shall be calibrated at two
points located approximately 1/3 and 2/3 of full-scale on each scale;

(B) logarithmic scale instruments shall be calibrated at
the midrange of each decade and at two points in the same decade for at least
one decade; and

(C) digital instruments shall be calibrated in
accordance with procedures that include the following calibration points:

(i) 2 mR/hr or 0.02 mSv/hr;

(ii) 5 mR/hr or 0.05 mSv/hr;

(iii) 50 mR/hr or 0.5 mSv/hr;

(iv) 500 mR/hr or 5 mSv/hr; and

(v) 1 R/hr or 0.01 Sv/hr;

(3) so that an accuracy within plus or minus 20
percent of the calibration standard can be demonstrated on each scale.

(c) Instrumentation required by this Rule shall have a
range such that two milliroentgens (0.02 millisieverts) per hour through one
roentgen (0.01 sievert) per hour can be measured.

(d) Survey instruments shall be checked for operability
prior to use. This may be accomplished by evaluating the instrument response
to the previously measured fields at the projection sheath port or the control
cable sheath port on a radiographic exposure device.

(e) The licensee or registrant shall maintain records of
the results of the instrument calibrations in accordance with Rule .0523 of
this Section.

History Note: Filed as A Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(a) The replacement of any sealed source fastened to or
contained in a radiographic exposure device and leak testing of any sealed
source shall be performed only by persons specifically authorized by the agency
to do so pursuant to the rules in this Section.

(b) The opening, repair, or modification of any sealed
source shall be performed only by persons specifically named in a license
condition to perform that function.

(c) Each sealed source shall be tested for leakage at
intervals not to exceed six months. In the absence of a certificate from a
transferor that a test has been made within the six months prior to the
transfer, the sealed source shall not be put into use until tested.

(d) The wipe of a sealed source shall be performed using a
leak test kit or similar materials and methods. The wipe sample shall be taken
from the nearest accessible point to the sealed source. The wipe sample shall
be analyzed for radioactive contamination. The analysis shall be capable of
detecting 0.005uCi (185 Bq) of radioactive material on the test sample and
shall be performed by persons licensed or registered by the agency to perform
such a service.

(e) Any test conducted pursuant to Paragraphs (c) and (d)
of this Rule which reveals the presence of 0.005 microcurie (185 Bq) or more of
removable radioactive material shall be considered evidence that the sealed
source is leaking. The licensee shall immediately withdraw the equipment
involved from use and shall cause it to be decontaminated and repaired or to be
disposed of, in accordance with these Rules. A report describing the equipment
involved, the test results, and the corrective action taken shall be submitted
in writing to the agency at the address in Rule .0111 of this Chapter within
five days after the test.

(f) The licensee shall maintain records of the leak test
results in accordance with Rule .0523 of this Section.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

Each licensee or registrant shall maintain current
utilization logs for inspection by the agency at the address specified in the
license, showing for each sealed source and radiation machine the information
required by Rule .0523(a)(6) of this Section.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(a) The licensee or registrant shall not permit any person
to act as a radiographer until the person:

(1) has been instructed in the subjects
outlined in Rule .0519 of this Section and has demonstrated understanding
thereof by successful completion of a written test. The
person shall also have a minimum of two months of on-the-job training, and be
certified through a radiography certification program by a certifying entity in
accordance with the requirements of Rule .0525 of this Section;

(2) has received copies of and instruction in
the rules contained in this Section and in the applicable rules of Sections .0200,
.0300, .0900 and .1600 of this Chapter, in applicable U.S. Department of
Transportation regulations referenced in Rule .0117 of this Chapter, and the
licensee's or registrant's operating and emergency procedures, and has
demonstrated understanding thereof by successful completion of a written test;

(3) has received training in the use of the
licensee or registrant's radiographic exposure devices, sealed sources, in the
daily inspection of devices and associated equipment, and in the use of
radiation survey instruments;

(4) has demonstrated competence to use the
radiographic exposure devices, sealed sources, related handling tools,
radiation machines and survey instruments which will be employed in his
assignment by successful completion of a practical examination covering this
material; and

(5) has demonstrated understanding of the
instructions in Paragraph (a) of this Rule by successful completion of a
written test on the subjects covered.

(b) The licensee or registrant shall not permit any person
to act as a radiographer's assistant until the person:

(1) has received copies of and instructions in
the licensee's or registrant's operating and emergency procedures, and has
demonstrated understanding thereof by successful completion of a written or
oral test and practical examination on the subjects covered;

(2) has demonstrated competence to use under
the personal supervision of the radiographer, the radiographic exposure
devices, sealed sources, related handling tools, radiation machines and
radiation survey instruments which will be employed in his assignment; and

(3) has demonstrated understanding of the
instructions in Paragraph (b) of this Rule by successfully completing a written
or oral test and a field examination on the subjects covered.

(c) Records of the training including copies of written
tests and dates of oral tests and field examinations shall be maintained in
accordance with Rule .0523 of this Section.

(d) Each licensee or registrant shall conduct an internal
audit program to ensure that the agency's radioactive material license,
registration conditions and the licensee's or registrant's operating and
emergency procedures are followed by each radiographer and radiographer's
assistant. These internal audits shall be performed and records maintained by
the licensee or registrant as specified in Items (3) and (4) of Rule .0323 of
this Chapter.

(e) The licensee or registrant shall provide periodic
training for radiographers and radiographer's assistants at least once during
every 12 months.

(f) Whenever radiography is performed outside of a
permanent radiographic installation, the radiographer shall be accompanied by
another radiographer or an individual with, at least, the qualifications of a
radiographer's assistant. This person's responsibilities shall include but not
be limited to observing the operations and being capable and prepared to
provide immediate assistance to prevent unauthorized entry.

(g) A licensee or registrant may conduct lay-barge,
off-shore platform, or underwater radiography only if procedures have been
developed and submitted to the agency that ensure radiation exposure to the
workers and the public are ALARA during the radiographic operation.

(h) The radiation safety officer shall ensure that
radiation safety activities are being performed in accordance with approved
procedures and regulatory requirements in the daily operation of the licensee's
or registrant's program.

(1) The radiation safety officer's
qualifications shall include:

(A) completion of the training and testing requirements
of Paragraph (a) of this Rule; and

(B) Two thousand hours documented experience in
industrial radiographic operations, with at least 40 hours of classroom
training with respect to the establishment and maintenance of radiation protection
programs; or

(C) an equivalent combination of education and
experience.

(2) The specific duties and authorities of the
radiation safety officer shall include, but are not limited to the following:

(A) to establish and oversee operating, emergency and ALARA
procedures, and to review them at least annually to assure that the procedures
are current and conform with these Rules and to the license conditions;

(B) to oversee and approve all phases of the training of
radiographic personnel so that appropriate and effective radiation protection
practices are taught;

(C) to ensure that required radiation surveys and leak
tests are performed and documented in accordance with this Rule, including any
corrective measures when levels of radiation exceed established limits;

(D) to ensure that personnel monitoring devices are
calibrated and used properly by occupationally-exposed personnel, that records
are kept of the monitoring results, and that timely notifications are made as
required by Rule .1646 of this Chapter;

(E) to assure that operations are conducted safely and
to assume control and have the authority to institute corrective actions
including stopping of operations when necessary in emergency situations or
unsafe conditions.

(a) Prior to use each day, the licensee or registrant shall
visually check for obvious defects in radiographic exposure devices, storage
containers, source changers, radiation machines and associated equipment. The
purpose of the visual check is to assure that the radiographic exposure
devices, storage containers, source changers, radiation machines and associated
equipment are in good working condition and that the required labeling is
present. If defects are found, the affected radiographic exposure devices,
storage containers, source changers, radiation machines and associated
equipment shall be removed from service until repaired and a record shall be
made in accordance with Rule .0523 of this Section.

(b) Each exposure device using depleted uranium (DU)
shielding and an "S" tube configuration shall be tested for DU
contamination at intervals not to exceed 12 months. This test shall be
performed by the licensee using procedures approved by the agency pursuant to
Rule .0323 of this Chapter or by the licensee returning the exposure device to
the manufacturer for such testing. If the test reveals the presence of DU
contamination, the exposure device shall be removed from use and arrangements
for proper disposal shall be made.

(c) Each licensee or registrant shall have written
procedures for:

(1) inspection and maintenance or radiographic
exposure devices, transport and storage containers, source changers, survey
instruments, radiation machines and associated equipment at intervals not to
exceed three months or prior to the first use thereafter to assure proper
functioning of components important to safety. Records of these inspections
and maintenance shall be made in accordance with Rule .0523 of this Section. If
defects are found, the affected radiographic exposure and associated equipment
shall be removed from service until repaired and a record made in accordance
with Rule .0523 of this Section.

(2) inspection and maintenance necessary to
maintain Type B packaging used to transport radioactive materials. The
inspection and maintenance program shall include procedures to assure that Type
B packages are shipped and maintained in accordance with the certificate of
compliance or other approval.

(d) Records of equipment problems and of any maintenance
performed under Paragraphs (a) and (b) of this Rule shall be made in accordance
with Rule .0523 of this Section.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(a) The licensee or registrant shall not permit any
individual to act as a radiographer or a radiographer's assistant unless, at
all times during radiographic operations, each such individual wears on the
trunk of the body a direct reading pocket dosimeter, an operating alarm
ratemeter, and a personnel dosimeter that is processed and evaluated by an
accredited National Voluntary Laboratory Accreditation Program (NVLAP)
processor. At permanent radiography facilities where other alarming or warning
devices are in routine use, the wearing of an alarming ratemeter is not
required. Direct reading pocket dosimeters shall have a range from zero to 200
milliroentgens (2 millisieverts) and shall be recharged at the start of each
shift. Each personnel dosimeter shall be assigned to and worn by only one
individual. Film badges shall be exchanged at least monthly, and other
personnel dosimeters that are processed and evaluated by an accredited NVLAP
processor shall be exchanged at least once each three months. Each film badge
or other personnel dosimeter shall be submitted for processing within 30 days
of replacement.

(b) Electronic personal dosimeters may be used in place of
direct reading ion-chamber pocket dosimeters.

(c) Direct reading dosimeters such as electronic personal
dosimeters or pocket dosimeters shall be read and exposures recorded at the
beginning and end of each shift.

(d) Direct reading dosimeters such as pocket dosimeters or
electronic personal dosimeters shall be checked at periods not to exceed 12
months for correct response to radiation. Acceptable dosimeters shall read
within plus or minus 20 percent of the true radiation exposure.

(e) If an individual's pocket dosimeter is found to be
off-scale or if the individual's electronic personal dosimeter reads greater
than 200 millirem (2 millisieverts), and the possibility of radiation exposure
cannot be ruled out as the cause, the individual's personnel dosimeter shall be
immediately sent for processing. In addition, the individual shall not work
with sealed sources until a determination of his radiation exposure has been
made by the radiation safety officer or his designee.

(f) If a personnel dosimeter is lost or damaged, the worker
shall cease work immediately until a replacement personnel dosimeter is
provided and exposure is calculated for the time period from issuance to loss
or damage of the personnel dosimeter.

(g) Each alarm ratemeter shall:

(1) be checked to ensure that the alarm
functions properly prior to use at the start of each shift;

(2) be set to give an alarm signal at a preset
rate not to exceed 500 mR/hr or 5 mSv/hr;

(3) require special means to change the preset
alarm function;

(4) alarm within plus or minus 20 percent of
the true radiation rate;

(5) be calibrated at periods not to exceed one
year for correct response to radiation.

(h) Records of daily dosimeter readings, determination of
exposure as a result of a lost or damaged personnel dosimeter, 12 month
response checks on dosimeters and results from the accredited NVLAP personnel
dosimeter processor shall be maintained in accordance with Rule .0523 of this
Section.

(i) Notwithstanding the requirements of Paragraph (a) of
this Rule, the agency may approve a higher pocket dosimeter range upon written
request by the licensee or registrant if the agency determines that the
requested range shall afford the protection required by the rules in this
Chapter.

History Note: Authority G.S. 104E‑7; 104E‑12(a)(2);

Eff. February 1, 1980;

Temporary Amendment Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

The licensee's or registrant's operating and emergency
procedures shall include instructions in at least the following:

(1) the handling and use of licensed sealed sources of
radiation and radiographic exposure devices to be employed such that no
individual is likely to be exposed to radiation doses in excess of the limits
established in Rule .1604 of this Chapter;

(2) methods and occasions for conducting radiation
surveys;

(3) methods for controlling access to radiographic
areas;

(4) methods and occasions for locking and securing
radiographic exposure devices, transport and storage containers and sealed
sources of radiation;

(5) personnel monitoring and the use of personnel
monitoring equipment;

(6) transportation of sealed sources to field
locations, including packing of radiographic exposure devices, and storage
containers in the vehicles, placarding of vehicles, and control of sealed
sources during transportation;

(7) minimizing exposure of individuals in the event of
an accident;

(8) the procedure for notifying proper personnel in the
event of an accident;

During each radiographic operation the radiographer or
radiographer's assistant shall maintain a continuous direct surveillance of the
operation to protect against unauthorized entry into a high radiation area, as
defined in Rule .0104 of this Chapter, except where the high radiation area:

(1) is equipped with a control device or an alarm
system as described in Rule .1615 of this Chapter, or

(2) is locked to protect against unauthorized or
accidental entry.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994 for a period of 180 days or until the

(a) No radiographic operation shall be conducted unless
calibrated and operable radiation survey instrumentation as described in Rule
.0506 of this Section is available and used at each site where radiography is
performed, including sealed source exchange and at the storage area whenever a
radiographic exposure device, a storage container or sealed source is being
placed in storage.

(b) A survey with a radiation detection instrument shall be
made after each radiographic exposure to determine that the sealed source has
returned to its shielded position in the radiographic exposure device or the
radiation machine is off. For sealed sources, the licensee shall conduct a
survey of the guide tube as the radiographer or radiographer's assistant
approaches the camera. The survey must determine that the sealed source has
returned to its shielded position prior to exchanging films, repositioning the
exposure head or dismantling the radiographic exposure device and associated
equipment.

(c) When the use of a radiographic exposure device or
storage container is to be terminated at the end of a work period, a survey
with a radiation detection instrument shall be made of the locked radiography
device or storage container to determine that the sealed source is in its
shielded position.

(d) A survey of the radiographic exposure device and source
changer shall be performed with a radiation detection instrument any time the
sealed source is exchanged and whenever a radiographic exposure device is
placed in a storage area.

(e) An area survey of the perimeter of the restricted area
with a radiation detection instrument shall be made with the sealed source
exposed or the radiation machine on before or during the initial radiographic
exposure on each shift and when the sealed source or the radiation machine
target configuration for an exposure is different from that of the preceding
exposure such that the radiation exposure rate at the perimeter of the
restricted area is likely to increase by a measurable amount using a radiation
detection instrument. These surveys are not required for radiography performed
in a permanent radiographic installation.

(f) Records of surveys required by this Rule shall be
maintained in accordance with the requirements of Rule .0523 of this Section.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

Notwithstanding any provisions in Rule .1625 of this
Chapter, areas in which radiography is being performed shall be conspicuously
posted as required by Rule .1624 of this Chapter. The exception listed in Rule
.1625 of this Chapter does not apply to industrial radiography.

(a) Whenever a radiographer's assistant uses radiographic
exposure devices or radiation machines, uses sealed sources or related source
handling tools, or conducts radiation surveys required by Rule .0515(b) and (c)
of this Section to determine that the exposure has been terminated and, if
applicable, the sealed source has returned to the shielded position after an
exposure, the assistant shall be under the personal supervision of a
radiographer.

(b) The personal supervision shall include:

(1) the radiographer's physical presence at the
site where the sealed sources or radiation machines are being used;

(2) the availability of the radiographer to
give immediate assistance, if required; and

(3) the radiographer's direct observation of
the assistant's performance of the operations referred to in this Section.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(a) Permanent radiographic installations having high
radiation area entrance controls of the types described in Subparagraphs
(a)(1), (2) and (3) of Rule .1615 of this Chapter shall also meet the following
special requirements:

(1) Each entrance that is used for personnel
access to the high radiation area in a permanent radiographic installation to
which this Section applies shall have both visible and audible warning signals
to warn of the presence of radiation.

(2) The visible signal shall be actuated by
radiation whenever the sealed source is exposed.

(3) The audible signal shall be actuated when
an attempt is made to enter the installation while the sealed source is
exposed.

(b) The alarm system shall be tested for proper operation
with a radiation source at the beginning of each day of equipment use. The
daily test shall include a check of the visible and audible signals by exposing
the sealed source or operating the radiation machine prior to use of the room.
Entrance control devices that reduce the radiation level upon entry as required
in Paragraph (a) of this Rule shall be tested monthly. If a control device or
alarm is operating improperly, it shall immediately be labeled as defective and
repaired within seven calendar days. The facility may continue to to be used
during this seven day period, provided the licensee or registrant implements
continuous surveillance to protect against unauthorized entry and uses an
alarming ratemeter.

(c) Records of test of alarm functions shall be maintained
in accordance with Rule .0523 of this Section.

History Note: Filed as a Temporary Amendment Eff.
August 20, 1994, for a period of 180 days or until the permanent rule becomes
effective, whichever is sooner;

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

History Note: Authority G.S. 104E-7;

Temporary Adoption Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

(a) In addition to the reporting requirements specified in
other rules of this Chapter, each licensee or registrant shall provide a
written report to the agency at the address specified in Rule .0111 of this Chapter
within 30 days of the occurrence of any of the following incidents involving
radiographic equipment:

(1) unintentional disconnection of the source
assembly from the control cable;

(2) inability to retract the source assembly to
its fully shielded position and secure it in this position; or

(3) failure of any component critical to safe
operation of the device to properly perform its intended function.

(b) The licensee or registrant shall include the following
information in each report required by Paragraph (a) of this Rule, and in each
report of overexposure submitted pursuant to Section .1600 which involves
failure of safety components of radiography equipment:

(1) a description of the equipment problem;

(2) cause of each incident, if known;

(3) manufacturer and model number of equipment
involved in the incident;

(4) place, time and date of the incident;

(5) actions taken to establish normal
operations;

(6) corrective actions taken or planned to
prevent recurrence; and

(7) qualifications of personnel involved in the
incident.

(c) Any licensee or registrant conducting radiographic
operations or storing radioactive material at any location not listed on the
license for a period in excess of 180 days in a calendar year, shall notify the
agency prior to exceeding the 180 days.

History Note: Authority G.S. 104E-7;

Temporary Adoption Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

(11) records of reports received from the
accredited National Voluntary Laboratory Accreditation Program (NVLAP)
personnel dosimetry processor. These records, as well as any records of
exposure estimates required as a result of off-scale direct reading dosimeters,
or lost or damaged personnel dosimeters, shall be maintained until the agency
terminates the license or registration or until authorized by the agency;

(12) records of exposure device surveys performed
at the end of the work day and prior to placing the device in storage;

(13) records of area surveys required by Rule
.0515 of this Section;

(14) copy of current operating and emergency
procedures until the agency terminates the license or registration and copies
of superseded material shall be retained for three years after the change is
made; and

(15) evidence of the latest calibrations of alarm
ratemeters and operability checks of pocket dosimeters or electronic personal
dosimeters.

(b) Each licensee or registrant conducting operations at
temporary jobsites shall maintain copies of the following documents and records
at the temporary jobsite until the radiographic operation is completed:

(1) operating and emergency procedures required
by Rule .0513 of this Section;

(2) radioactive materials license or
registration;

(3) evidence of training of the radiographers
and radiographer's assistants. The individuals shall either be listed on the
radioactive materials license or registration and offer identification or shall
have certification of his training and offer identification;

(4) evidence of the latest calibration of the
radiation detection instrumentation in use at the site as required by Rule
.0506 of this Section;

(5) evidence of the latest leak test of the
sealed source required by Rule .0507 of this Section;

(6) records of the latest surveys required by
Rule .0515 of this Section;

(7) records of current direct reading
dosimeters such as pocket dosimeter or electronic personal dosimeter readings;

(8) shipping papers for the transportation of
radioactive materials required by 10 CFR Part 71.5; and

(9) records of area surveys required by Rule
.0515 of this Section;

(10) a copy of Section .0500 of this Chapter;

(11) utilization records for each radiographic
exposure device dispatched from that location as required by Subparagraph (a)
of Rule .0523 of this Section;

(12) records of equipment problems identified in
daily checks of equipment; and

(13) when operating under reciprocity, a copy of
the Nuclear Regulatory Commission or agreement state license authorizing the
use of radioactive material.

(c) Each record required by this Rule shall be legible
throughout the specified retention period. The record may be an original, a
reproduced copy or microform provided that the copy or microform is authenticated
by the licensee and the microform is capable of reproducing a clear copy
throughout the required record retention period. The record may also be stored
in electronic media with the capability for producing legible, accurate and
complete records during the required record retention period. Records, such as
letters, drawings and specifications shall include all pertinent information,
such as stamps, initials and signatures. The licensee or registrant shall
maintain safeguards against tampering with and loss of records.

History Note: Authority G.S. 104E-7;

Temporary Adoption Eff. August 20, 1994, for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

An application for a specific license for the use of
licensed material in industrial radiography shall be approved if the applicant
meets the following requirements:

(1) the applicant satisfies the general requirements
specified in Rules .0317 and .0323 of this Chapter for radioactive material, as
appropriate, and any special requirements contained in this Section;

(2) the applicant submits a program for training
radiographers and radiographers' assistants, that meets the requirements of
Rule .0323 of this Chapter and Rule .0510 of this Section.

(3) the applicant submits procedures for verifying and
documenting the certification status of radiographers and for ensuring that the
certification of individuals acting as radiographers remains valid;

(4) the applicant submits written operating and
emergency procedures as described in Rule .0323 of this Chapter and Rule .0513
of this Section;

(5) the applicant submits a description of a program
for inspections of the job performance of each radiographer and radiographers'
assistant at intervals not to exceed six months as described in Rule .0323 of
this Chapter;

(6) the applicant submits a description of the
applicant's overall organizational structure as it applies to the radiation
safety responsibilities in industrial radiography, including specified
delegation of authority and responsibility;

(7) the applicant identifies and lists the
qualifications of the individual(s) designated as the radiation safety officer
and potential designees responsible for ensuring that the licensee's radiation
safety program is implemented in accordance with the requirements of this
Chapter;

(8) If an applicant intends to perform leak testing of
sealed sources or exposure devices containing depleted uranium shielding, the
applicant shall describe the procedures for performing and the qualifications
of the person(s) authorized to do the leak testing. If the applicant intends
to analyze its own wipe samples, the application shall include a description of
the procedures to be followed. The description shall include the:

(a) instruments to be used;

(b) methods of performing the analysis; and

(c) pertinent experience of the person who will
analyze the wipe samples;

(9) If the applicant intends to perform
"in-house" calibrations of survey instruments, the applicant shall
describe methods to be used and the relevant experience of the person(s) who
will perform the calibrations. All calibrations shall be performed according
to the procedures described and at the intervals prescribed in Rule .0506 of
this Section;

(10) The applicant identifies and describes the
location(s) of all field stations and permanent radiographic installations; and

(11) The applicant identifies the locations where all
records required by this Section and other Sections of this Chapter will be
maintained.

(1) be an organization such as the American
Society of Nondestructive Testing (ASNT) or other society or association, whose
members participate in, or have an interest in, the field of industrial
radiography;

(2) make its membership available to the
general public nationwide that is not restricted because of race, color,
religion, sex, age, national origin or disability;

(3) have a certification open to nonmembers, as
well as members;

(4) be an incorporated, nationally recognized
organization, such as ASNT, that is involved in setting national standards of
practice within its field of expertise;

(5) have staff, a viable system for financing
its operations, and policy and decision-making review board;

(6) have a set of written organizational
by-laws and policies that provide assurance of lack of conflict of interest and
a system for monitoring and enforcing those by-laws and policies;

(7) have a committee, whose members can carry
out their responsibilities impartially, to review and approve the certification
guidelines and procedures, and to advise the organization's staff in
implementing the certification program;

(8) have a committee, whose members can carry
out their responsibilities impartially, to review complaints against certified
individuals and to determine appropriate sanctions;

(9) have written procedures describing all
aspects of its certification program, maintain records of the current status of
each individual's certification and the administration of its certification
program;

(10) have procedures to ensure that certified
individuals are provided due process with respect to the administration of its
certification program, including the process of becoming certified and any
sanctions imposed against certified individuals;

(11) have procedures for proctoring examinations,
including qualifications for proctors;

(12) ensure that the procedures in Subparagraph
(a)(11) of this Paragraph require that the individuals proctoring each
examination are not employed by the same company or corporations (or a
wholly-owned subsidiary of such company or corporation) as any of the
examinees;

(13) exchange information about certified
individuals with the agency and other independent certifying organizations or
the U.S. Nuclear Regulatory Commission and other agreement states, and allow
periodic review of its certification program and related records; and

(14) provide a description to the agency of its
procedures for choosing examination sites and for providing an environment
suitable for examination.

(b) All certification programs shall:

(1) require applicants for certification to
receive training in the topics set forth in Rule .0519 of this Section and
satisfactorily complete a written examination covering the topics in Rule .0519
of this Section;

(2) require applicants for certification to
provide documentation that demonstrates that the applicant has:

(A) received training in the topics set forth in Rule
.0519 of this Section; or

(B) satisfactorily completed a minimum period of
on-the-job training; and

(C) received verification by an agreement state or a
Nuclear Regulatory Commission licensee that the applicant has demonstrated the
capability of independently working as a radiographer;

(3) include procedures to ensure that all
examination questions are protected for disclosure;

(4) include procedures for denying an
application, and for revoking, suspending, and reinstating a certification;

(5) provide a certification period of not less
than three years and not more than five years;

(6) include procedures for renewing
certifications and, if the procedures allow renewals without examination,
require evidence of recent full-time employment and annual refresher training;
and

(7) provide a timely response to inquiries by
telephone or letter, from members of the public, about an individual's
certification status.

(c) All examinations shall be:

(1) designed to test an individual's knowledge
and understanding of the topics set forth in Rule .0519 of this Section;

(2) written in a multiple-choice format; and

(3) have test items drawn from a question list
based on the material contained in Rule .0519 of this Section.

This Section establishes requirements for use of x‑ray
equipment by or under the supervision of an individual authorized by and
licensed in accordance with state statutes to engage in the healing arts or
veterinary medicine. The provisions of this Section are in addition to, and not
in substitution for, the provisions of Sections .0100, .0200, .0900, .1000, and
.1600 of this Chapter.

(1) "Accessible surface" means the
external surface of the enclosure or housing provided by the manufacturer.

(2) "Added filter" means the filter
added to the inherent filtration.

(3) "Aluminum equivalent" means the
thickness of aluminum, type 1100 alloy, affording the same attenuation, under
specified conditions, as the material in question. The nominal composition of
type 1100 aluminum alloy is 99.00 percent minimum aluminum and 0.12 percent
copper.

(4) "Attenuation block" means a block
or stack, having dimensions 20 cm by 20 cm by 3.8 cm, of type 1100 aluminum
alloy or other materials having equivalent attenuation.

(5) "Automatic exposure control"
means a device which automatically controls one or more technique factors in
order to obtain, at a preselected location(s), a required quantity of
radiation. Phototimer is described separately.

(6) "Beam axis" means a line from the
source of x‑rays through the centers of the x‑ray fields.

(7) "Beam‑limiting device"
means a device which provides a means to restrict the dimensions of the x‑ray
field.

(8) "Cephalometric device" means a
device intended for the radiographic visualization and measurement of the
dimensions of the human head.

(9) "Changeable filters" means any
added filter which can be removed from the useful x‑ray beam through any
electronic, mechanical or physical process.

(10) "Contact therapy system" means
that the x‑ray tube target is put within five centimeters of the surface
being treated.

(11) "Control panel" means that part of
the x‑ray control upon which are mounted the switches, knobs, pushbuttons
and other hardware necessary for manually setting the technique factors.

(15) "Diagnostic‑type protective tube
housing" means a tube housing so constructed that the leakage radiation
measured at a distance of one meter from the source does not exceed 100 mR in one
hour when the tube is operated at its leakage technique factors.

(16) "Diagnostic x‑ray system"
means an x‑ray system designed for irradiation of any part of the human
body for the purpose of diagnosis or visualization.

(17) "Direct scattered radiation" means
that radiation which has been deviated in direction by materials irradiated by
the useful beam.(See also scattered radiation).

(18) "Entrance exposure rate" means the
roentgens per unit time at the point where the center of the useful beam enters
the patient.

(19) "Exposure" means the quotient of
dQ by dm where "dQ" is the absolute value of the total charge of the
ions of one sign produced in air when all the electrons, negatrons and
positrons, liberated by photons in a volume element of air having mass
"dm" are completely stopped in air. The special unit of exposure is
the roentgen.

(20) "Field emission equipment" means
equipment which uses an x‑ray tube in which electron emission from the
cathode is due solely to the action of an electric field.

(22) "Fluoroscopic imaging assembly"
means a subsystem in which x‑ray photons produce a fluoroscopic image.
It includes the image receptor(s) such as the image intensifier and spot‑film
device, electrical interlocks and structural material providing linkage between
the image receptor and the diagnostic source assembly.

(24) "Gonad shield" means a protective
barrier used to reduce exposure to the testes or ovaries.

(25) "Half‑value layer (HVL)"
means the thickness of specified material which attenuates the beam of
radiation to an extent such that the exposure rate is reduced to one‑half
of its original value. In this definition the contribution of all scattered
radiation, other than any which might be present initially in the beam concerned,
is deemed to be excluded.

(26) "Healing arts mass screening"
means the examination of human beings using x‑rays for the detection or
evaluation of health indications when such tests are not specifically and
individually ordered by a licensed practitioner of the healing arts who is
legally authorized to prescribe such x‑ray tests for the purpose of
diagnosis or treatment. It does not include the use of x‑ray tests as a
requirement for hospital admission or as a condition of employment.

(27) "Image intensifier" means a
device, including housing, which converts an x‑ray pattern into a
corresponding light image of higher energy density.

(28) "Image receptor" means any device,
such as fluorescent screen or radiographic film, which transforms incident x‑ray
photons either into a visible image or into another form which can be made into
a visible image by further transformations.

(29) "Inherent filtration" means the
filtration permanently in the useful beam; it includes the window of the x‑ray
tube and any permanent tube or source enclosure.

(30) "Installation" means the act of
physical movement of a radiographic system from one location to another in
conjunction with a change of ownership.

(31) "Lead equivalent" means the
thickness of lead affording the same attenuation, under specified conditions,
as the material in question.

(B) radiation produced when the exposure switch or timer
is not activated.

(33) "Leakage technique factors" means
the technique factors associated with the diagnostic or therapeutic source
assembly (i.e., tube housing and beam limiting device) which are used in
measuring leakage radiation. They are defined as follows:

(A) for diagnostic source assemblies intended for
capacitor energy storage equipment, the maximum rated peak tube potential and
the maximum rated number of exposures in an hour for operation at the maximum
rated peak tube potential with the quantity of charge per exposure being 10
millicoulombs (mC) or the minimum obtainable from the unit, whichever is
larger;

(B) for diagnostic source assemblies intended for field
emission equipment rated for pulsed operation, the maximum rated peak tube potential
and the maximum rated number of x‑ray pulses in an hour for operation at
the maximum rated peak tube potential; and

(C) for all other diagnostic or therapeutic source
assemblies, the maximum rated peak tube potential and the maximum rated continuous
tube current for the maximum rated peak tube potential.

(34) "Light field" means that area of
the intersection of the light beam from the beam‑limiting device and one
of the set of planes parallel to and including the plane of the image receptor,
whose perimeter is the locus of points at which the illumination is one‑fourth
of the maximum in the intersection.

(35) "Maximum line current" means the
rms (root‑mean‑square) current in the supply line of an x‑ray
machine operating at its maximum rating.

(36) "Mobile equipment" (see x‑ray
equipment).

(37) "Peak tube potential" means the
maximum value of the potential difference across the x‑ray tube during an
exposure.

(38) "Phototimer" means a method for
controlling radiation exposures to image receptors by the amount of radiation
which reaches a radiation monitoring device(s). The radiation monitoring
device(s) is part of an electronic circuit which controls the duration of time
the tube is activated (see also "Automatic exposure control").

(39) "Portable equipment" (see x‑ray
equipment).

(40) "Position indicating device (PID)"
means a device on dental x‑ray equipment used to indicate the beam
position and to establish a definite source‑skin distance. It may or may
not incorporate or serve as a beam‑limiting device.

(42) "Protective apron" means an apron
made of radiation attenuating materials used to reduce radiation exposure.

(43) "Protective barrier" means a
barrier of radiation attenuating material(s) used to reduce radiation
exposure. Types of protective barriers are defined in other items of this
Rule.

(44) "Protective glove" means a glove
made of radiation attenuating materials used to reduce radiation exposure.

(45) "Qualified expert" means an
individual who is registered pursuant to Rule .0205 of this Chapter.

(46) "Radiograph" means an image
receptor on which the image has been created directly or indirectly by an x‑ray
pattern and results in a permanent record.

(47) "Radiographic imaging system"
means any system whereby a permanent or semi‑permanent image is recorded
on an image receptor by the action of ionizing radiation.

(48) "Rating" means the operating
limits as specified by the component manufacturer.

(49) "Recording" means producing a
permanent form of an image resulting from x‑ray photons such as film and
video tape.

(50) "Registrant", as used in this
Section, means any person who owns or possesses and administratively controls
an x‑ray system which is used to deliberately expose humans or animals to
the useful beam of the system and is required by the provisions contained in
Sections .0100 and .0200 of this Chapter to register with the agency.

(51) "Response time" means the time
required for an instrument system to reach 90 percent of its final reading when
the radiation‑sensitive volume of the instrument system is exposed to a
step change in radiation flux from zero sufficient to provide a steady state
mid‑scale reading.

(52) "Scattered radiation" means
radiation that, during passage through matter, has been deviated in direction.
(See also "direct scattered radiation".)

(B) for field emission equipment rated for pulsed
operation, peak tube potential in kV and number of x‑ray pulses; and

(C) for all other equipment, peak tube potential in kV
and either tube current in mA and exposure time in seconds, or the product of
tube current and exposure time in mAs.

(61) "Therapeutic‑type protective tube
housing" means the tube housing with tube installed, and it includes high
voltage and filament transformers and other appropriate elements when they are
contained within that housing.

(62) "Transportation equipment" means x‑ray
equipment which is installed in a vehicle or trailer.

(63) "Tube" means an x‑ray tube,
unless otherwise specified.

(64) "Tube housing assembly" means the
tube housing with tube installed. It includes high‑voltage and filament
transformers and other appropriate elements when they are contained within the
tube housing.

(65) "Tube rating chart" means the set
of curves which specify the rated limits of operation of the tube in terms of
the technique factors.

(66) "Useful beam" means the radiation
which passes through the tube housing port and the aperture of the beam‑limiting
device when the exposure switch or timer is activated.

(67) "Variable‑aperture beam‑limiting
device" means a beam‑limiting device which has capacity for stepless
adjustment of the x‑ray field size at the given SID.

(68) "Visible area" means that portion
of the input surface of the image receptor over which incident x‑ray
photons produce a visible image.

(69) "X‑ray control" means a
device which controls input power to the x‑ray high‑voltage
generator or the x‑ray tube. It includes equipment such as timers,
phototimers, automatic brightness stabilizers and similar devices which control
the technique factors of an x‑ray exposure.

(A) "Mobile equipment" means x‑ray
equipment mounted on a permanent base with wheels or casters for moving while
completely assembled.

(B) "Portable equipment" means x‑ray equipment
designed to be hand‑carried.

(C) "Stationary equipment" means x‑ray
equipment which is installed in a fixed location.

(71) "X‑ray field" means that
area of the intersection of the useful beam and any one of the set of planes
parallel to and including the plane of the image receptor, whose perimeter is
the locus of points at which the exposure rate is one‑fourth of the
maximum in the intersection.

(72) "X‑ray high‑voltage
generator" means a device which transforms electrical energy from the
potential supplied by the x‑ray control to the tube operating potential.
The device may also include means for transforming alternating current to
direct current, filament transformers for the x‑ray tube(s), high‑voltage
switches, electrical protective devices and other appropriate elements.

(73) "X‑ray system" means an
assemblage of components for the controlled production of x‑rays. It
includes minimally an x‑ray high‑voltage generator, an x‑ray
control, a tube housing assembly, a beam‑limiting device and the necessary
supporting structures. Additional components which function with the system
are considered integral parts of the system.

(74) "X‑ray subsystem" means any
combination of two or more components of an x‑ray system for which there
are requirements specified in this Section.

(75) "X‑ray tube" means an
electron tube which is designed for the conversion of electrical energy into x‑ray
energy.

(b) Other definitions applicable to this Section may be
found in Sections .0100 and .0200 of this Chapter.

(1) The registrant shall be responsible for
directing the operation of the x‑ray machines which he has registered
with the agency. He or his agent shall assure that the following provisions
are met in the operation of the x‑ray machine(s):

(A) An x‑ray machine which does not meet the
provisions of these Rules shall not be operated for diagnostic or therapeutic
purposes, if so ordered by the agency in accordance with Rules .0109 and .0110
of this Chapter.

(B) Individuals who will be operating the x‑ray
equipment shall be instructed in the safe operating procedures and use of the
equipment and demonstrate an understanding thereof to the registrant.

(C) In the vicinity of each diagnostic x‑ray
system's control panel, a chart shall be provided, which specifies for all
usual examinations and associated projections which are performed by that
system, a listing of information including patient's anatomical size versus
technique factors to be utilized at a given source to image receptor distance.
The chart shall also provide:

(i) type and size of the film or film‑screen
combination to be used,

(ii) type and ratio of grid to be used, if any, and
focal spot to film distance,

(iii) type and placement of gonad shielding to be
used.

(D) Written safety procedures and rules shall be
established and made available to each individual operating x‑ray
equipment under his control. The operator shall be familiar with these rules.

(E) Only the professional staff and ancillary personnel
required for the medical procedure or for training shall be in the room during
the radiographic exposure. Other than the patient being examined:

(i) All individuals shall be positioned such that
no part of the body including the extremities which is not protected by 0.5 mm
lead equivalent will be exposed to the useful beam.

(ii) Professional staff and ancillary personnel
shall be protected from the direct scatter radiation by protective aprons or
whole body protective barriers of not less than 0.25 mm lead equivalent.

(iii) Patients who cannot be removed from the room
shall be protected from the direct scatter radiation by whole body protective
barriers of 0.25 mm lead equivalent or shall be so positioned that the nearest
portion of the body is at least six feet from both the tube head and the
nearest edge of the image receptor.

(iv) When a portion of the body of a non-
occupationally exposed professional staff or ancillary personnel is potentially
subjected to stray radiation which would result in that individual receiving
one‑fourth of the maximum permissible dose as defined in Rule .1604 of
this Chapter, additional protective measures shall be employed.

(v) Upon written application to the agency, the
agency may waive the requirements in Subparts (a)(1)(E)(ii) and (a)(1)(E)(iii)
of this Rule if the registrant demonstrates that such waiver is necessary for
best management of patients and will not result in violation of the public and
occupational dose limits established in the rules in this Chapter.

(F) Gonad shielding of not less than 0.5 mm lead
equivalent shall be used for potentially procreative patients during
radiographic procedures in which the gonads are in the direct, or useful beam,
except for cases in which this would interfere with the diagnostic procedures.

(G) Individuals shall not be exposed to the useful beam
except for healing arts purposes. Such exposures shall have been authorized by
a licensed practitioner of the healing arts. This provision specifically prohibits
deliberate exposure of an individual for training, demonstration or other
nonhealing arts purposes.

(H) When a patient or film must be provided with
auxiliary support during a radiographic exposure:

(i) Mechanical holding devices shall be used whenever
medical circumstances permit. Written safety procedures, as required in Part
(a)(1)(D) of this Rule shall indicate the requirements for selecting a holder;

(ii) If a human holder is required, written safety
procedures as required in Part (a)(1)(D) of this Rule, shall indicate the
instructions provided to the holder;

(iii) The human holder shall be protected as required
in Part (a)(1)(E) of this Rule;

(iv) No individual shall be used routinely to hold
patients or film.

(I) Procedures and auxiliary equipment designed to
minimize patient and personnel exposure commensurate with the needed diagnostic
information shall be utilized. This includes, but is not limited to, the
following requirements:

(i) The speed of film or screen and film
combinations shall be the fastest speed consistent with the diagnostic
objective of the examinations.

(ii) The radiation exposure to the patient shall be
the minimum exposure required to produce images of good diagnostic quality.

(iii) Portable or mobile equipment shall be used only
for examinations where it is impractical for medical reasons to transfer the
patient to a stationary radiographic installation.

(J) All persons who are associated with the operation
of an x‑ray system are subject to the occupational exposure limits as
defined in Rules .1604 and .1638 of this Chapter, and personnel monitoring
procedures in Rule .1614 of this Chapter. In addition, when protective
clothing or equipment is worn on portions of the body and a monitoring
device(s) is required, at least one such monitoring device shall be utilized as
follows:

(i) When an apron is worn the monitoring device
shall be worn at the collar outside the apron.

(ii) The dose to the whole body shall be recorded in
the reports required in Rule .1640 of this Chapter. If more than one device is
used, each dose shall be identified with the area where the device was worn on
the body.

(2) The registrant shall maintain at least the
following information for each x‑ray machine:

(A) current registration information and other correspondence
with the agency regarding that machine;

(B) records of surveys and calibrations;

(C) records of maintenance or modifications which affect
the useful beam after the effective date of these Rules, along with the names
of persons who performed the service.

(b) Plans Review. Prior to construction or structural
modification, the floor plans and equipment arrangement of all installations
utilizing x‑rays for diagnostic or therapeutic purposes shall be reviewed
by a qualified expert. The registrant shall submit recommendations of the
expert to the agency.

(c) Radiation Survey

(1) For installations of x‑ray equipment
after the effective date of this Rule, an area radiation survey shall be
performed within 30 days following initial operation of each radiation machine
to show compliance with Rule .0604(b) of this Section. This survey shall
include:

(A) a drawing of the room in which a stationary x‑ray
system is located and radiation levels in adjacent areas; and

(B) the name of the person approved by the agency
performing the survey and the date the survey was performed.

(2) Any modification to the x‑ray room or
adjacent areas which could increase the radiation dosage to any individual
shall require a new survey.

(3) Records of this survey shall be maintained
in accordance with Subparagraph (a)(2) of this Rule.

(a) In addition to other requirements of this Section, all
diagnostic x‑ray systems shall meet the following requirements:

(1) The control panel containing the main power
switch shall bear the warning statement, legible and accessible to view:
"WARNING: This x‑ray unit may be dangerous to patient and operator
unless safe exposure factors and operation instructions are observed."

(2) Equivalent wording may be used on battery‑powered
generators; visual means shall be provided on the control panel to indicate
whether the battery is in a state of charge adequate for proper operation.

(3) The leakage radiation from the diagnostic
source assembly measured at a distance of one meter in any direction from the
source shall not exceed 100 millirem in one hour when the x‑ray tube is
operated at its leakage technique factors. Compliance shall be determined by
measurements averaged over an area of 100 square centimeters with no linear
dimension greater than 20 centimeters.

(4) The radiation emitted by a component other
than the diagnostic source assembly shall not exceed two millirem in one hour
at five centimeters from any accessible surface of the component when it is
operated in an assembled x‑ray system under any conditions for which it
was designed. Compliance shall be determined by measurements averaged over an
area of 100 square centimeters with no linear dimension greater than 20
centimeters.

(5) Beam Quality

(A) Half‑Value Layer

(i) The half‑value layer (HVL) of the useful
beam for a given x‑ray tube potential shall not be less than the
appropriate value shown in the following table. "Specified Dental
System" is any dental x‑ray system designed for use with intraoral
image receptors and manufactured after December 1, 1980. "Other X‑Ray
Systems" shall be all other x‑ray systems subject to this Section.

X‑Ray Tube
Voltage (kilovolt peak) Minimum
HVL Minimum HVL

(millimeters (millimeters

of
Aluminum) of Aluminum)

Measured Specified Other

Designed
operating Operating Dental X‑ray

range Potential Systems Systems

Below 50‑‑‑‑‑‑‑‑‑‑‑‑ 30 1.5 0.3

40 1.5 0.4

49 1.5 0.5

50 to 70‑‑‑‑‑‑‑‑‑‑‑‑ 50 1.5 1.2

60 1.5 1.2

70 1.5 1.5

Above 70‑‑‑‑‑‑‑‑‑‑‑‑ 71 2.1 2.1

80 2.3 2.3

90 2.5 2.5

100 2.7 2.7

110 3.0 3.0

120 3.2 3.2

130 3.5 3.5

140 3.8 3.8

150 4.1 4.1

If it is necessary to determine such half‑value layer
at an x‑ray tube potential which is not listed in the table, linear
interpolation or extrapolation may be made. Positive means shall be provided
to insure that at least the minimum filtration needed to achieve the above beam
quality requirements is in the useful beam during each exposure.

(ii) The requirements of Subpart (a)(5)(A)(i) of
this Rule shall be considered to be met if it can be demonstrated that the
aluminum equivalent of the total filtration in the primary beam is not less
than that shown in the following table:

Filtration Required versus Operating
Voltage

Minimum
total filtration

Operating Voltage (kVp)
(inherent plus added)

(millimeters
aluminum

equivalent)

Below 50 0.5
millimeters

50 ‑ 70 1.5
millimeters

Above 70 2.5
millimeters

(iii) Notwithstanding the requirements of Subpart
(a)(5)(A)(ii) of this Rule, all intraoral dental systems manufactured after
December 1, 1980, shall have a minimum of 1.5 mm aluminum equivalent filtration
permanently installed in the useful beam.

(v) For capacitor energy storage equipment,
compliance shall be determined with the maximum quantity of charge per
exposure.

(vi) The required minimum aluminum equivalent
filtration shall include the filtration contributed by all materials which are
always present between the focal spot of the tube and the patient, such as a
tabletop when the tube is mounted under the table and inherent filtration of
the tube.

(B) For new x‑ray systems installed after the effective
date of these Rules and which have variable kVp and selectable filtration for
the useful beam, a device shall link the kVp selector with the filter(s), so
that the minimum filtration is always present for the kVp selected.

(6) Where two or more radiographic tubes are
controlled by one exposure switch, the tube or tubes which have been selected
and their location shall be clearly indicated on the master control panel prior
to initiation of the exposure.

(7) The tube housing assembly supports shall be
adjusted such that the tube housing assembly will remain stable during an
exposure unless the tube housing movement is a design function of the x‑ray
system.

(8) The location of the focal spot may be
indicated on a readily visible area of the x‑ray source housing in the
plane parallel to the image receptor when the image receptor is perpendicular
to the beam axis.

(9) Technique Indicators

(A) The technique factors to be used during an exposure
shall be indicated before the exposure begins, except when automatic exposure
controls are used, in which case the technique factors which are set prior to
the exposure shall be indicated.

(B) Indication of technique factors shall be visible
from the operator's position except in the case of spot films made by the fluoroscopist.

(C) On equipment having fixed technique factors, the
recommendation in Part (a)(9)(A) of this Rule may be met by permanent markings.

(b) Structural Shielding

(1) For stationary diagnostic systems, except
for intraoral dental systems which shall meet the requirements of Rule .0607(j)
of this Section, structural shielding shall be provided to assure compliance
with Rules .1604 and .1611 of this Chapter. The following shall be provided:

(A) All wall, floor and ceiling areas exposed to the
useful beam shall have primary barriers. Primary barriers in walls shall
extend to a minimum height of 84 inches above the floor;

(B) Secondary barriers in the wall, floor and ceiling
areas not having a primary barrier or where the primary barrier requirements are
lower than the secondary barrier requirements; and

(C) A window of lead‑equivalent glass equal to
that required by the adjacent barrier or a mirror system shall be provided
large enough and so placed that the operator can see the patient without having
to leave the protected area during exposures.

(2) When a mobile system is used routinely in
one location, the structural shielding in that location shall meet the
requirements for stationary diagnostic systems in Subparagraph (b)(1) of this
Rule.

(a) The fluoroscopic tube shall not produce x‑rays
unless the primary protective barrier is in position to intercept the entire
useful beam at all times.

(b) The entire cross section of the useful beam
shall be intercepted by the primary protective barrier of the fluoroscopic
image assembly at any SID.

(c) Limitation to the Imaging Surface

(i) The x‑ray field produced by
fluoroscopic equipment without image intensification shall not extend beyond
the entire visible area of the image receptor. This requirement applies to
field size during both fluoroscopic procedures and spot‑filming
procedures.

(ii) Image‑intensified fluoroscopy and
spot‑filming shall comply with the following:

(A) During fluoroscopic or spot‑filming
procedures, neither the length nor the width of the x‑ray field in the
plane of the image receptor shall exceed the visible area of the image receptor
by more than three percent of the SID. The sum of the excess length and the
excess width shall be no greater than four percent of the SID.

(B) Compliance shall be determined with the beam
axis perpendicular to the image receptor. For rectangular x‑ray fields
used with circular image reception, the error in alignment shall be determined
along the length and width dimensions of the x‑ray field which pass
through the center of the visible area of the image receptor.

(iii) In addition to other requirements of this
Rule, equipment manufactured after the effective date of these Rules shall
comply with the following:

(A) Means shall be provided between the source
and the patient for adjustment of the x‑ray field size in the plane of
the film to the size of that portion of the film which has been selected on the
spot‑film selector. This adjustment shall be automatically accomplished
except when the x‑ray field size in the plane of the film is smaller than
that of the selected portion of the film.

(B) It shall be possible to adjust the x‑ray
field size in the plane of the film to a size smaller than the selected portion
of the film. The minimum field size at the greatest SID, shall be equal to or
less than five centimeters by five centimeters.

(C) The center of the x‑ray field in the
plane of the film shall be aligned with the center of the selected portion of
the film to within two percent of the SID.

(2) X‑ray production in the fluoroscopic mode
shall be controlled by a device which requires continuous pressure by the
fluoroscopist for the entire time of any exposure. When recording serial
fluoroscopic images, the fluoroscopist shall be able to terminate the x‑ray
exposure(s) at any time, but means may be provided to permit completion of any
single exposure of the series in process.

(3) Entrance exposure rates shall be limited as
required in the following:

(a) Fluoroscopic equipment shall not be operated
at any combination of tube potential and current which will result in an
exposure rate in excess of ten roentgens per minute at the point where the
center of the useful beam enters the patient, except:

(i) during recording of fluoroscopic images; or

(ii) when provided with optional high level
control, the equipment shall not be operable at any combination of tube
potential and current which will result in an exposure rate in excess of five
roentgens per minute at the point where the center of the beam enters the
patient unless the high level control is activated. Special means of
activation of high level controls, such as additional pressure applied
continuously by the operator, shall be required to avoid accidental use. A
continuous signal audible to the fluoroscopist shall indicate that the high
level control is being employed.

(b) In addition to the other requirements of
this Rule equipment manufactured after August, 1974, which does not incorporate
an automatic exposure control (e.g., automatic brightness control or ionization
chamber control) shall not be operated at any combination of tube potential and
current which will result in an exposure rate in excess of five roentgens per
minute at the point where the center of the useful beam enters the patient
except during the recording of fluoroscopic images or when provided with an
optional high level control.

(c) Compliance with the provisions of Item (3)
of this Rule shall be determined as follows:

(i) Movable grids and compression devices shall
be removed from the useful beam during the measurement.

(ii) If the source is below the table, the
exposure rate shall be measured one centimeter above the tabletop or cradle.

(iii) If the source is above the table, the
exposure rate shall be measured at 30 centimeters above the tabletop with the
end of the beam‑limiting device or spacer positioned as closely as
possible to the point of measurement.

(iv) In a C‑arm type fluoroscope, the
exposure rate shall be measured 30 centimeters from the input surface of the
fluoroscopic imaging assembly.

(i) Such measurements shall be made every two
years or after any maintenance of the system which might affect the exposure
rate.

(ii) Results of these measurements shall be
available or posted where any fluoroscopist may have ready access to them and
shall be in the record required in Rule .0603(a)(2)(B) of this Section.
Results of the measurements shall include the exposure rate, as well as the
physical factors used to determine all data; the name of the person approved by
the agency performing the measurements and the date the measurements were
performed.

(iii) Entrance exposure rate shall be determined
with the attenuation block in Rule .0602(a) in the primary beam.

(4) Radiation transmitted through the primary
protective barrier of the fluoroscopic imaging assembly shall comply with the
following requirements:

(a) The exposure rate resulting from
transmission through the primary protective barrier with the attenuation block
in the useful beam, combined with radiation from the image intensifier, if
provided, shall not exceed two milliroentgens per hour at ten centimeters from
any accessible surface of the fluoroscopic imaging assembly beyond the plane of
the image receptor for each roentgen per minute of entrance exposure rate.

(b) Measurements to determine compliance with
Sub-item (4)(a) of this Rule shall be in accordance with the following:

(i) The exposure rate resulting from
transmission through the primary protective barrier combined with radiation
from the image intensifier shall be determined by measurements averaged over an
area of 100 square centimeters with no linear dimension greater than 20
centimeters;

(ii) If the source is below the tabletop, the
measurement shall be made with the input surface of the fluoroscopic imaging
assembly, positioned 30 centimeters above the tabletop.

(iii) If the source is above the tabletop and the
SID is variable, the measurement shall be made with the end of the beam‑limiting
device or spacer as close to the tabletop as it can be placed, provided that it
shall not be closer than 30 centimeters;

(iv) Movable grids and compression devices shall
be removed from the useful beam during the measurement;

(v) The attenuation block shall be positioned in
the useful beam ten centimeters from the point of measurement of entrance
exposure rate and between this point and the input surface of the fluoroscopic
imaging assembly.

(5) During fluoroscopy and cinefluorography, x‑ray
tube potential and current shall be continuously indicated.

(a) Means shall be provided to preset the
cumulative on‑time of the fluoroscopic tube. The maximum cumulative time
of the timing device shall not exceed five minutes without resetting.

(b) A signal audible to the fluoroscopist shall
indicate the completion of any preset cumulative on‑time. Such signal
shall continue to sound while x‑rays are produced until the timing device
is reset.

(8) Mobile fluoroscopes, in addition to the other
requirements of this Rule, shall provide image intensification.

(9) Scattered radiation shall be controlled in
accordance with the following requirements:

(a) A shielding device of at least 0.25 mm lead
equivalent for covering the Bucky slot during fluoroscopy shall be provided.

(b) A shield of at least 0.25 mm lead
equivalent, such as overlapping protective drapes or hinged or sliding panels,
shall be provided to intercept scattered radiation which would otherwise reach
the fluoroscopist and others near the machine.

(c) Upon application to the agency with adequate
justification, exceptions from Sub-items (9)(a) or (9)(b) of this Rule may be
made in some special procedures where a sterile field will not permit the use
of the normal protective barriers or where the protective barriers would
interfere with the procedures.

(a) Unless specifically provided otherwise by the rules in
this Chapter, the requirements in this Rule shall apply to all x‑ray
systems, except for fluoroscopic and dental intraoral x‑ray systems. The
useful beam of x‑ray systems subject to provisions of this Rule shall be
limited to the area of clinical interest or the image receptor, whichever is
smaller.

(1) General purpose stationary and mobile x‑ray
systems shall meet the following special requirements:

(A) There shall be provided a means for stepless
adjustment of the size of the x‑ray field. The minimum field size at a
SID of 100 centimeters shall be equal to or less than five centimeters by five
centimeters.

(B) Means shall be provided for visually defining the
perimeter of the x‑ray field. The total misalignment of the edges of the
visually defined field with the respective edges of the x‑ray field along
either the length or width of the visually defined field shall not exceed two
percent of the distance from the source to the center of the visually defined
field when the surface upon which it appears is perpendicular to the axis of
the x‑ray beam.

(C) Notwithstanding Parts (a)(1)(A) and (B) of this
Rule, equipment manufactured before August 1, 1974 may employ fixed cones and
diaphragms or variable collimators without beam defining lights.

(2) In addition to the requirements of
Subparagraph (a)(1) of this Rule, all stationary x‑ray systems, except
equipment originally manufactured before the effective date of this Rule, shall
meet the following requirements:

(A) Means shall be provided to indicate when the axis of
the x‑ray beam is perpendicular to the plane of the image receptor, to
align the center of the x‑ray field with respect to the center of the
image receptor to within two percent of the SID, and to indicate the SID to
within two percent;

(B) The beam limiting device shall numerically indicate
the field size in the plane of the image receptor to which it is adjusted;

(C) Indication of field size dimensions and SID's shall
be specified in inches or centimeters and shall be such that aperture
adjustments result in x‑ray field dimensions in the plane of the image
receptor which correspond to those of the image receptor to within two percent
of the SID when the beam axis is perpendicular to the plane of the image
receptor.

(3) Radiographic equipment designed for only
one image receptor size at a fixed SID shall be provided with means to limit
the field at the plane of the image receptor to dimensions no greater than
those of the image receptor and to align the center of the x‑ray field
with the center of the image receptor to within two percent of the SID.

(4) Special purpose x‑ray systems shall
meet the following requirements:

(A) These systems shall be provided with means to limit
the x‑ray field in the plane of the image receptor so that such field
does not exceed each dimension of the image receptor by more than two percent
of the SID when the axis of the x‑ray beam is perpendicular to the plane
of the image receptor.

(B) Such systems shall also be provided with means to
align the center of the x‑ray field with the center of the image receptor
to within two percent of the SID.

(C) The requirements in Parts (a)(4)(A) and (B) of this
Rule may be met with a system that meets the requirements for a general purpose
x‑ray system as specified in Subparagraph (a)(1) of this Rule or, when
alignment means are also provided, as follows:

(i) an assortment of removable, fixed‑aperture,
beam‑limiting devices sufficient to meet the requirement for each
combination of image receptor size and SID for which the unit is designed,
where each device has clear and permanent markings to indicate the image
receptor size and SID for which it is designed; or

(ii) a beam‑limiting device having multiple
fixed apertures sufficient to meet the requirement for each combination of
image receptor size and SID for which the unit is designed, where the device
has permanent, clearly legible, markings indicating image receptor size and SID
for which the unit is designed, where the device has permanent, clearly
legible, markings indicating image receptor size and SID for which each
aperture is designated and indicating which aperture is in position for use.

(b) Radiation exposure control devices shall meet the
following requirements:

(1) Means shall be provided to terminate the
exposure after a preset time interval, preset product of current and time, a
preset number of pulses or a preset radiation exposure to the image receptor.
In addition:

(A) Termination of exposure shall cause automatic
resetting of the timer to its initial setting or to zero except during serial
radiography, and

(B) It shall not be possible to make an exposure when
the timer is set to a zero or "off" position if either position is
provided.

(2) Control over x‑ray exposures shall be
in accordance with the following requirements:

(A) A control shall be incorporated into each x‑ray
system such that the operator can terminate an exposure at any time except for
serial radiography where means may be provided to permit completion of any
single exposure of the series in process.

(B) Each x‑ray control shall be located in such a
way as to meet the following criteria.

(i) For stationary x‑ray systems, the control
shall be permanently mounted in a protected area so that the operator is
required to remain in that protected area during the entire exposure; and

(ii) The x‑ray control shall provide visual
indication observable at or from the operator's protected position whenever x‑rays
are produced. In addition, except for equipment originally manufactured before
the effective date of this Rule, a signal audible to the operator shall
indicate that the exposure has terminated.

(3) When an automatic exposure control (e.g.,
phototimer) is provided the following requirements shall be met, except
equipment originally manufactured before the effective date of this Rule:

(A) Indication shall be made on the control panel when
this mode of operation is selected;

(B) When the x‑ray tube potential is equal to or
greater than 50 kVp, the minimum exposure time for field emission equipment
rated for pulsed operation shall be equal to or less than a time interval
equivalent to two pulses;

(C) The minimum exposure time for all equipment other
than that specified in Part (b)(3)(B) of this Rule shall be equal to or less
than 1/60 second or a time interval required to deliver five mAs, whichever is
greater;

(D) Either the product of peak x‑ray tube
potential, current and exposure time shall be limited to not more than 60 kWs
per exposure or the product of x‑ray tube current and exposure time shall
be limited to not more than 600 mAs per exposure except when the x‑ray
tube potential is less than 50 kVp, in which case the product of x‑ray
tube current and exposure time shall be limited to not more than 2000 mAs per
exposure; and

(E) A visible signal shall indicate when an exposure
has been terminated at the limits described in Part (b)(3)(D) of this Rule and
manual resetting shall be required before further automatically timed exposures
can be made.

(4) When four timer tests are performed at
identical timer setting equal to 5.0 seconds or less, the average time period
(T) shall be greater than five times the difference between the maximum period
(Tmax) and the minimum period (Tmin) in accordance with the formula:

All radiographic systems shall be provided with a durable,
securely fastened means to limit the source‑skin distance to at least 30
centimeters. This is considered to be met when the collimator or cone provides
the required limits.

(d) The exposure produced shall be reproducible to within
the following criteria:

When all technique factors are held constant, the
coefficient of variation shall not exceed 0.10. This shall be deemed to be met
if, when four exposures at identical technique factors are made, the value of
the average exposure (E)is greater than five times the difference between the
maximum exposure (Emax) and the minimum exposure (Emin) in accordance with the
formula:

E > 5(Emax‑Emin)

(e) Standby radiation from capacitor energy storage
equipment, when the exposure switch or timer is not activated, shall not exceed
a rate of two milliroentgens per hour at five centimeters from any accessible
surface of the diagnostic source assembly with the beam‑limiting device
fully open.

(f) Linearity

(1) When the equipment allows a choice of x‑ray
tube current settings, the average ratios of exposure to the indicated
milliampere‑seconds product, i.e., mR/mAs, obtained at any two
consecutive tube current settings shall not differ by more than 0.10 times
their sum, i.e., /mean of x1‑ x2/ < minus 0.10 mean of (x1+ x2), where
the mean of x1 and x2 are the average mR/mAs values obtained at each of two
consecutive tube current settings.

(2) Compliance shall be determined at the most
commonly used mA stations by measuring mR/mAs at those stations and at one
adjacent station to each.

(g) Timer accuracy

(1) For indicated values of 0.10 seconds and
above, the measured value shall be within plus or minus 15 percent of the
indicated values for equipment manufactured before August 1, 1974.

(2) For equipment manufactured after August 1,
1974, the deviation of measured values from indicated values shall not exceed
the limits specified for that system by its manufacturer.

(a) In addition to the provisions of Rules .0603 and .0605
of this Section, the requirements of this Rule apply to x‑ray equipment
and associated facilities used for dental radiography. Criteria for extraoral
dental radiographic systems are covered in Rule .0606 of this Section.

(b) X‑ray systems designed for use with an intraoral
image receptor shall be provided with means to limit source‑skin distance
to not less than:

(1) 18 centimeters, if operated above 50
kilovolts peak; or

(2) ten centimeters, if operated at or below 50
kilovolts peak.

(c) The size of the direct radiation beam shall be limited
in accordance with the following rules:

(1) Radiographic systems designed for use with
an intraoral image receptor shall be provided with means to limit the x‑ray
beam such that:

(A) If the source‑skin distance (SSD) is 18
centimeters or more, the x‑ray field at the SSD shall be containable in a
circle having a diameter of no more than seven centimeters; and

(B) If the SSD is less than 18 centimeters, the x‑ray
field at the SSD shall be containable in a circle having a diameter of no more
than six centimeters.

(2) Effective February 1, 1981, equipment
manufactured prior to August 1974 shall be equipped with a lead line open
position indicating device with at least 0.79 mm lead.

(d) The timing device shall comply with the following
requirements:

(1) Termination of the exposure after a preset
interval;

(2) Termination of exposure shall cause
automatic resetting of the timer to its initial setting or to zero;

(3) It shall not be possible to make an
exposure when the timer is set to a zero or "off" position if either
position is provided; and

(4) When four timer tests are performed at
identical timer settings equal to five seconds or less, the average time period
(T) shall be greater than five times the difference between the maximum period
(Tmax) and the minimum period (Tmin) in accordance with the formula:

(A) For indicated values of 0.10 seconds and above, the
measured value shall be within plus or minus 15 percent of the indicated values
for equipment manufactured before August 1, 1974.

(B) For equipment manufactured after August 1, 1974, the
deviation of measured values from indicated values shall not exceed the limits
specified for that system by its manufacturer.

(e) The exposure switch shall comply with the following
requirements:

(1) A control shall be incorporated into each x‑ray
system such that an exposure can be terminated at any time, except for
exposures of one‑half second or less.

(2) Each x‑ray control shall be located
in such a way as to meet the following criteria:

(A) For stationary x‑ray systems installed after
the effective date of this Rule, the exposure switch shall be permanently
mounted in a protected area (e.g., corridor outside the room) so that the
operator is required to remain in that protected area during the entire
exposure.

(B) For stationary x‑ray systems without a
protected area and installed before the effective date of this Rule, the
exposure switch shall be such that the operator shall stand at least six feet
away from the tube and out of the direct beam.

(C) For mobile and portable x‑ray systems the
switch shall meet the requirements of Part (e)(2)(B) of this Rule.

(3) For equipment manufactured after August 1,
1974, the x‑ray control shall provide visual indication observable at or
from the operator's protected position whenever x‑rays are produced. In
addition, a signal audible to the operator shall indicate that the exposure has
terminated.

(f) The exposure produced shall be reproducible to within
the following criteria:

When all technique factors are held constant, the
coefficient of variation shall not exceed 0.10. This shall be deemed to be met
if, when four exposures at identical technique factors are made, the value of
the average exposure (E) is greater than five times the difference between the
maximum exposure (Emax) and the minimum exposure (Emin) in accordance with the
formula:

E > 5(Emax‑
Emin)

(g) Patient and film holding devices shall be used when the
techniques permit.

(h) Neither the tube housing nor the position indicating
device shall be hand‑held during an exposure.

(i) Dental fluoroscopy without image intensification shall
not be used.

(j) Structural shielding

(1) All wall, floor and ceiling areas shall
have protective barriers sufficient to meet the requirements of Rules .1604 and
.1611 of this Chapter.

(2) When intraoral x‑ray systems are
installed in adjacent rooms or areas, protective barriers as specified in
Subparagraph (j)(1) of this Rule shall be provided between the rooms or areas.

(a) Unless specifically provided otherwise by the rules in
this Chapter, the requirements in this Rule shall apply only to therapeutic x‑ray
installations which are not capable of operating at or above one MeV.
Therapeutic x‑ray equipment subject to the provisions of this Rule shall
comply with the following requirements:

(1) When the tube is operated at its leakage
technique factors, the leakage radiation in any direction shall not exceed the
value specified at the distance specified for the classification of that x‑ray
system.

(A) For contact therapy systems, the leakage radiation
shall not exceed 100 mR/hr at five centimeters from the tube housing.

(B) Systems operating from zero to 150 kVp which are
manufactured or installed prior to the effective date of this Rule shall have a
leakage radiation which does not exceed one R in one hour at one meter from the
source.

(C) Systems operating from zero to 150 kVp which are
manufactured on or after the effective date of this Rule shall have a leakage
radiation which does not exceed 100 mR in one hour at one meter from the
source.

(D) Systems operating from 151 to 999 kVp shall have
leakage radiation which does not exceed one R in one hour at one meter from the
source, except systems which operate in excess of 500 kVp may have a leakage
radiation in one hour at one meter from the source equivalent to 0.1 percent of
the exposure in the useful beam in one hour at a distance of one meter from the
source.

(2) Permanent beam limiting devices used for
collimating the useful beam shall provide the same or higher degree of
protection as that required by the tube housing assembly.

(3) Adjustable or removable beam limiting
devices shall transmit not more than five percent of the useful beam as
determined at the maximum tube potential and maximum treatment filter.

(4) The filter system shall be so designed
that:

(A) Filters cannot be accidentally displaced from the
useful beam at any tube orientation;

(B) Each filter is marked as to its material of
construction and its thickness or wedge angle for wedges;

(C) It shall be possible for the operator to determine
the presence of and identify each filter and the orientation of each wedge
filter in the useful beam when the operator is positioned at the control panel
either by display at the control panel or by direct observation;

(D) The filters and filter insertion slot opening shall
be so designed that the radiation at five centimeters from the filter insertion
slot opening does not exceed 30 roentgens per hour under all operating
conditions; and

(E) Each machine equipped with a beryllium or other low
filtration window shall be clearly labeled as such upon the tube head housing
and upon the control panel.

(6) The tube housing assembly shall be so
marked that it is possible to determine the location of the focal spot to
within five millimeters and such marking shall be readily accessible.

(7) Equipment of greater than 150 kVp installed
after the effective date of this Rule shall be provided with a beam monitor
system.

(8) The exposure timer shall meet the following
requirements:

(A) A timer shall be provided which has a display at the
treatment control panel. The timer shall have a preset time selector and shall
terminate irradiation when a preselected time has elapsed.

(B) The timer shall switch on and off with the radiation
and retain its reading after irradiation is interrupted or terminated.

(9) The control panel shall have:

(A) an indication of whether electrical power is present
and activation of the x‑ray tube is possible;

(B) an indication of whether x‑rays are being
produced;

(C) the means for indicating kVp and x‑ray tube current;

(D) the means for terminating an exposure at any time;

(E) a locking device which will prevent unauthorized
use of the x‑ray system and, for systems not having a lock at the control
panel, an alternate method of preventing unauthorized use, shall be provided;

(F) for equipment manufactured after the effective date
of this Rule, a positive display of specific filter(s) in the beam.

(10) When a control panel may energize more than
one x‑ray tube:

(A) It shall be possible to activate only one x‑ray
tube during any one time interval;

(B) There shall be an indication at the control panel
identifying which x‑ray tube can be energized; and

(C) There shall be an indication at the x‑ray tube
if that tubehead can be energized.

(11) There shall be means of determining the
target to patient distance to within one centimeter.

(12) If exposures are controlled by a timer, that
timer:

(A) shall permit the setting of exposure times at least
as short as one second, and

(B) shall not permit an exposure if set at zero or "off".

(13) Unless it is possible to bring the x‑ray
exposure rate to its prescribed value within five seconds of actuating the x‑ray
"on" control, the tube housing shall be fitted with a shutter
operable only from the control panel, and of lead equivalent not less than that
of the tube housing. In addition:

(A) The status of the shutter "Beam On",
"Beam Off" or "Shutter Open", "Shutter Closed" or
equivalent description, shall be indicated at the control panel.

(B) It shall not be possible to initiate an exposure
sequence unless the shutter has first been placed in the "Beam Off"
or "Shutter Closed" position.

(C) The shutter shall automatically go to the "Beam
Off" or "Shutter Closed" position if the exposure is terminated
by:

(i) the operation of the timer,

(ii) the dose monitoring system, if provided,

(iii) the operation of a safety interlock, or

(iv) a power failure.

(b) In addition to shielding adequate to meet requirements
of Section .1600 of this Chapter, the following treatment room design
requirements shall be met:

(1) Treatment room entrances shall be provided
with warning lights in a readily observable position, which will indicate when
the useful beam is "on".

(2) Provision shall be made for two‑way
communication with the patient from the control room.

(3) A system shall be provided to permit
continuous observation of the patient during irradiation and shall be so
located that the operator may see the patient and the control panel from the
same position.

(4) Facilities which contain an x‑ray
system which may be operated above 150 kVp shall:

(A) have all necessary shielding, except for any beam
interceptor, provided by fixed barriers;

(B) have the control panel in a protected area which is
outside the treatment room;

(C) have all entrance doors to the treatment room
electrically connected such that the x‑ray production cannot be initiated
unless all doors are closed and shall cease if any door is opened during x‑ray
production;

(D) if the radiation output of the x‑ray tube is
affected by any door opening, be so designed that it is possible to initiate x‑ray
production only by:

(i) closing all doors and, subsequently,

(ii) reinitiating the exposure by manual action at
the control panel.

(c) Operating procedures, surveys, and calibration shall
comply with the following requirements:

(1) All new facilities and existing facilities
not previously surveyed shall have a radiation protection survey made by, or
under the direction of, a qualified expert. This shall also be done after any
change in the facility which might produce a radiation hazard. The expert
shall report his findings in writing to the person in charge of the facility,
and a copy of this report shall be transmitted by the registrant to the agency
at the address in Rule .0111 of this Chapter.

(2) The radiation output of each therapeutic x‑ray
machine shall be calibrated by, or under the direction of a qualified expert
who is physically present at the facility during the calibration procedure.
The calibration shall be repeated after any change, in or replacement of,
components of the x‑ray generating equipment which could cause a change
in x‑ray output. Calibration of the therapy beam shall be performed with
a measurement instrument, the calibration of which is traceable to national
standards for exposure or absorbed dose, and which shall have been calibrated
within the preceding 12 months. Records of radiation outputs shall be provided
to and maintained by the registrant.

(3) Each therapeutic x‑ray machine shall
be calibrated as described in Subparagraph (c)(2) of this Rule at time
intervals not exceeding one year. The calibration shall include at least the
following determinations:

(A) the accurate determination of the air exposure rate
or the dose rate at a reference point within a suitable phantom, as
appropriate;

(B) the congruence between the radiation field and light
localizer, when such is used;

(C) the half‑value layer for every combination of
kVp and filter used for radiation therapy.

(4) Therapeutic x‑ray systems capable of
operation at greater than 150 kVp, in addition to the annual calibration
required in Subparagraphs (c)(2) and (3) of this Rule, shall have spot checks
performed.

(A) The spot check methods and frequency shall be
designed and in writing by a qualified expert. Spot checks shall include
verification of continued congruency between the radiation field and the
localizing device where an optical field illuminator is used.

(B) Whenever a spot check indicates a significant change
in the operating characteristics of a machine, as specified in the qualified
expert's spot check design, the machine shall be recalibrated as required.

(C) A log shall be kept of all spot check measurements.

(5) Therapeutic x‑ray machines shall not
be left unattended unless the locking device required by Part (a)(10)(E) of
this Rule is set to prevent activation of the useful beam.

(6) Except as provided in Rule .0603(a)(1)(H)
of this Section, no individual other than the patient shall be in the treatment
room during exposures unless he is protected by a barrier sufficient to meet
the requirements of Rule .1604 of this Chapter, and no individual other than
the patient shall be in the treatment room when the kVp exceeds 150 during
exposures.

(7) The tube housing assembly shall not be held
by hand during operation unless the system is designed to require such holding
and the peak tube potential of the system does not exceed 50 kVp. In such
cases the holder shall wear protective gloves and apron of not less than 0.5 mm
lead equivalency at 100 kVp.

(a) The requirements in Paragraphs (b) to (e) of this Rule
shall apply only to medical facilities using medical x‑ray and electron
therapy equipment with energies one MeV and above. In addition, such medical
facilities shall also comply with the requirements in Section .0900 of this
Chapter.

(b) Equipment requirements are as follows:

(1) For existing equipment and new equipment
manufactured or installed after the effective date of these Rules:

(A) The leakage radiation, excluding neutrons, at a
distance of one meter from the source shall not exceed 0.1 percent of the
useful beam dose rate at one meter from the source for any of its operating
conditions.

(B) Within one year after the effective date of these
Rules the registrant shall determine or obtain from the manufacturer for each
machine the leakage radiation specifications for electrons, x‑rays and
neutrons existing at the points specified in Part (b)(1)(A) of this Rule for
specified operating conditions. Records on radiation leakage shall be
maintained at the installation.

(C) For equipment from which neutron leakage may be a
hazard, a qualified expert shall specify such additional requirements as may be
necessary to protect health or minimize danger to life or property. The
adequacy of these additional requirements shall be confirmed by a survey.
Survey records shall be maintained by the registrant.

(2) Adjustable or interchangeable beam limiting
devices shall be provided and shall meet the following requirements:

(A) For existing equipment and new equipment
manufactured or installed after the effective date of these Rules:

(i) Adjustable or interchangeable beam limiting
devices shall attenuate the radiation incident on the beam limiting devices
such that the dose equivalent in rems at any distance from the source does not
exceed two percent of the maximum dose equivalent in the useful beam measured
at an equal distance from the radiation source.

(ii) If the beam limiting device does not meet the
specifications in Subpart (b)(2)(A)(i) of this Rule, the agency may accept
auxiliary equipment or methods for accomplishing attenuation.

(B) Dose equivalent measurements may be averaged over an
area up to but not exceeding 100 square centimeters at a distance of one meter
from the target.

(3) In equipment which uses a system of wedge
filters, interchangeable field flattening filters or beam scattering devices:

(A) Irradiation shall not be possible until a selection
of filter has been made at the treatment control panel;

(B) An interlock system shall be provided to prevent
irradiation if the filter is not in the correct position;

(C) An indication of the orientation of the wedge filter
with respect to the treatment field shall be provided when wedge filters are
used; and

(D) A display shall be provided at the treatment control
panel showing the filter(s) in use, including an indication of "no
filters".

(4) Equipment installed after the effective
date of these Rules shall be provided with at least one radiation detector in
the radiation head. This detector shall be incorporated into a primary
system.

(A) Each primary system shall have a detector which is a
transmission detector and is a full beam detector and is placed on the patient side
of any fixed added filters other than a wedge filter;

(B) The detector(s) shall be removable only with tools
or shall be interlocked to prevent incorrect positioning.

(C) Each detector shall be capable of independently
monitoring and turning "off" the useful beam.

(D) Each detector shall form part of a dose monitoring
system from whose readings in dose monitor units the absorbed dose at a
reference point in the treatment volume can be calculated.

(E) Each dose monitoring system shall have a legible
display at the treatment control panel which shall:

(i) maintain a reading until intentionally reset;

(ii) in the event of power failure, have the
capability of retrieving the information displayed at the time of failure.

(5) Selection and display of dose monitor units
shall comply with the following requirements:

(A) Irradiation shall not be possible until a selection
of a number of dose monitor units has been made at the treatment control panel.

(B) After useful beam termination, it shall be necessary
to reset the preselected dose monitor units before treatment can be
reinitiated.

(C) The preselected number of dose monitor units shall
be displayed at the treatment control panel until reset for the next
irradiation.

(6) Automatic termination of irradiation by the
dose monitoring system shall comply with the following requirements:

(A) Each of the monitoring systems shall be capable of
independently terminating irradiation. Provisions shall be made to test the
correct operation of each system.

(B) Each primary system shall terminate irradiation when
the preselected number of dose monitor units have been reached, and each
secondary system shall be used as a backup.

(7) It shall be possible to terminate
irradiation and equipment movements or to go from an interruption condition to
termination conditions at any time from the treatment control panel.

(8) It shall be possible to interrupt
irradiation and equipment movements at any time from the treatment control
panel. Following an interruption it shall be possible to restart irradiation
by operator action without any reselection of operating conditions. If any
change is made of a pre‑selected value during an interruption the
equipment shall go to termination condition.

(9) A timer shall be provided and shall meet the
following requirements:

(A) The timer shall have a display at the treatment
control panel. The timer shall have a preset time selector and an elapsed time
indicator.

(B) The timer shall be a cumulative timer which switches
"on" and "off" with the radiation and retains its reading
after irradiation is interrupted or terminated. It shall be necessary to zero
the elapsed time indicator and the preset time selector after irradiation is
terminated, before reactivation is possible.

(C) To guard against failure of the dose monitoring
systems, the timer shall terminate irradiation when a preselected time has
elapsed.

(10) In equipment capable of both x‑ray
therapy and electron therapy:

(A) Irradiation shall not be possible until a selection
of radiation type, x‑rays or electrons, has been made at the treatment
control panel;

(B) An interlock system shall be provided to prevent
irradiation if any selected operations carried out in the treatment room do not
agree with the selected operations carried out at the treatment control panel;

(C) An interlock system shall be provided to prevent
irradiation with x‑rays when electron applicators are fitted and
irradiation with electrons when x‑ray wedge filters are fitted; and

(D) The radiation type selected shall be displayed at
the treatment control panel before and during irradiation.

(11) In equipment capable of generating radiation
beams of different energies:

(A) Irradiation shall not be possible until a selection
of energy has been made at the treatment control panel;

(B) An interlock system shall be provided to insure that
the equipment emits primarily the energy of radiation which has been selected;

(C) An interlock system shall be provided to prevent
irradiation if any selected operations carried out in the treatment room do not
agree with the selected operations carried out at the treatment control panel;
and

(D) The energy selected shall be displayed at the
treatment control panel before and during irradiation.

(12) In equipment capable of both stationary‑beam
therapy and moving‑beam therapy:

(A) Irradiation shall not be possible until a selection
of stationary‑beam therapy or moving‑beam therapy has been made at
the treatment control panel;

(B) An interlock system shall be provided to prevent
irradiation if any selected operations carried out in the treatment room do not
agree with the selected operations carried out at the treatment control panel;

(C) An interlock system shall be provided to terminate
irradiation if the movement stops during moving‑beam therapy;

(D) Moving‑beam therapy shall be so controlled
that the required dose monitor units per degree of rotation is obtained; and

(E) The mode of operation shall be displayed at the
treatment control panel.

(13) The registrant shall determine or obtain
from the manufacturer the location with reference to an accessible point on the
radiation head of:

(A) the x‑ray target and the virtual source of x‑rays;

(B) the electron window or the scattering foil; and

(C) all possible orientations of the useful beam.

(14) Means shall be provided so that all
radiation safety interlocks can be checked. When preselection of any of the
operating conditions requires action in the treatment room and at the treatment
control panel selection at one location shall not give a display at the other
location until the requisite selection operations in both locations have been
completed.

(c) Facility shielding shall be adequate to meet the
requirements of Section .1600 of this Chapter.

(2) The control panel shall be located outside
the treatment room. The door must be closed during radiation production.

(3) A viewing system shall be provided to
permit continuous observation of the patient during irradiation and shall be so
located that the operator may see the patient and the control panel from the
same position. When the viewing system is by electronic means (e.g.,
television), an alternate viewing system shall be available.

(4) Provision shall be made for two‑way
aural communication with the patient from the control room, however, where
excessive noise levels make aural communication impractical, other methods of
communication shall be used.

(5) Treatment rooms to which access is possible
through more than one entrance shall be provided with warning lights, in a
readily observable position near the outside of all access doors, preferably at
eye level, which will indicate when the useful beam is "on".

(6) Have all entrance doors to the treatment
room electrically connected such that the x‑ray production cannot be
initiated unless all doors are closed and shall cease if any door is opened
during x‑ray production.

(e) The operating procedures which follow are in addition
to those in Rule .0908 of this Chapter.

(1) Radiation protection surveys shall comply
with the following requirements:

(A) All new facilities and existing facilities not
previously surveyed shall have a radiation protection survey made by, or under
the direction of, a qualified expert. This shall also be done after any change
in the facility or equipment which might cause a significant increase in
radiation hazard.

(B) The expert shall report his findings in writing to
the person in charge of the facility, and a copy of the report shall be
transmitted by the registrant to the agency at the address in Rule .0111 of
this Chapter.

(2) No person other than the patient shall be
in the treatment room during treatment. When a patient must be held in position
for radiation therapy, mechanical supporting or restraining devices shall be
used.

(3) The output of each therapeutic x‑ray
machine shall be calibrated by, or under the direct supervision of a qualified
expert, before it is first used for medical purposes. Calibrations shall be
repeated at least once every 12 months and after any change which might
significantly increase radiation hazards. Calibration of the therapy beam
shall be performed with measurement instruments, the calibration of which is
traceable to national standards for exposure or absorbed dose and which shall
have been calibrated within the preceding 12 months. Records of calibrations
shall be provided to and maintained by the registrant. The calibration shall
include at least the following determinations:

(A) the exposure rate or dose rate as appropriate for
the field sizes used and for each effective energy and for each treatment
distance used for radiation therapy;

(B) the beam quality (e.g., half‑value layer when
appropriate) for every proposed combination of operating conditions used for
radiation therapy;

(C) the congruence between the radiation field and the
field indicated by the localized device when used;

(D) verification that the equipment is operating in
compliance with the design specifications concerning the light localizer, the
side light and backpointer alignment with the isocenter, when applicable,
variation in the axis of rotation for the table, gantry and jaw system and beam
flatness and symmetry in air or at the specified depths in a water phantom.

(4) Spot checks shall be performed monthly.

(A) The spot check methods shall be in writing and shall
be designed by a qualified expert.

(B) Whenever a spot check indicates a significant change
(as specified in the qualified expert's spot check design) in the operating
characteristics of a machine, the machine shall be recalibrated as required in
Subparagraph (e)(3) of this Rule.

(a) The provisions of this Rule shall apply only to
veterinary medicine radiographic installations. Radiographic equipment used in
veterinary medicine radiographic installations shall meet the following
requirements:

(1) The protective tube housing shall be of the
diagnostic type.

(2) Diaphragms or cones shall be provided for
collimating the useful beam to the area of the image receptor and shall provide
the same degree of protection as is required in the housing.

(3) The total filtration permanently in the
useful beam shall not be less than 0.5 millimeters aluminum equivalent for
machines operating up to 50 kVp, 1.5 millimeters aluminum equivalent for
machines operating between 50‑70 kVp, and 2.5 millimeters aluminum
equivalent for machines operating above 70 kVp.

(4) A device shall be provided to terminate the
exposure after a preset time or exposure.

(5) A dead‑man type of exposure switch
shall be provided, together with an electrical cord of sufficient length, so
that the operator can stand out of the useful beam and at least six feet from
the animal during all x‑ray exposures or behind a protective barrier
adequate to assure compliance with Rules .1604 and .1611 of this Chapter.

(b) All wall, ceiling and floor areas shall be equivalent
to or provided with primary and secondary protective barriers necessary to
comply with Rules .1604 and .1611 of this Chapter.

(c) Operating procedures shall meet the following
requirements:

(1) The operator shall stand well away from the
useful beam and the animal during radiographic exposures.

(2) No individual other than the operator shall
be in the x‑ray room while exposures are being made unless such
individual's assistance is required.

(3) When an animal must be held in position
during radiography, mechanical supporting or restraining devices shall be used;
except if the animal must be held by an individual, that individual shall be
protected with appropriate shielding devices, such as protective gloves and
apron, and shall be so positioned that no part of the individual's body will be
struck by the useful beam. The exposure of any professional staff or ancillary
personnel used for this purpose shall be monitored and permanently recorded.
Exposures shall comply with Rules .1604 and .1609 of this Chapter.

(a) This Rule provides special requirements for human
diagnostic use of computed tomography (CT) x-ray equipment. The uses of Cone
Beam CT, Veterinary CT, CT Simulation, and CT attenuation correction shall be
exempt from this Rule. The provisions of this Rule are in addition to, and not
in substitution for, the Rules in Sections .0100, .0200, .0600, .0900, .1000,
and .1600 of this Chapter.

(b) The following definitions shall apply to this Rule:

(1) "CT qualified expert (CT QE)"
means an individual who is registered or is providing service for a registered
facility where they are employed, as required by Section .0200 of this Chapter.
The individual shall have the following education and experience:

(A) a master's or doctoral degree in physics, medical
physics, biophysics, radiological physics, medical health physics, or
equivalent disciplines from a college or university accredited by an agency
recognized by the U.S. Department of Education, and three years work experience
in a clinical CT environment. The work experience shall be supervised and
documented by a medical physicist certified in the specialty area of diagnostic
medical physics by the American Board of Radiology, the Canadian College of
Physicists in Medicine, or the American Board of Medical Physics; or

(B) certification in the specialty area of diagnostic
medical physics by the American Board of Radiology, the Canadian College of
Physicists in Medicine, or the American Board of Medical Physics and shall
abide by the certifying body's requirements for continuing education.

(2) "general supervision" means the
activity is performed under the qualified supervisor's overall direction and
control but the qualified supervisor's physical presence shall not be required
during the activity.

(3) "personal supervision" means
overall direction, control, and training of an individual by a qualified
supervisor who shall be physically present during the activities performed by
the supervised individual.

(c) Equipment and Installation Requirements

(1) CT x-ray systems shall meet the
requirements of 21 CFR 1020.33 as incorporated by reference in Rule .0117(a)(3)
of this Chapter.

(2) The operator of a CT scanner shall be able
to maintain aural communication with the patient from a shielded position at
the control panel.

(d) Personnel Requirements. Individuals who operate CT
x-ray systems shall be specifically trained on the operational features of the
unit and:

(1) hold (CT) registration with the American
Registry of Radiologic Technologists (ARRT); or

(2) be a Registered Technologist (R.T.) by the
ARRT with registration in radiography (R) or a Certified Nuclear Medicine
Technologist by the Nuclear Medicine Technology Certification Board; these
individuals shall document training and experience that is equivalent to that
required to attain (CT) registration with the ARRT; or

(3) be in training under the personal
supervision of an individual that meets the requirements of Subparagraph (d)(1)
or (d)(2) of this Rule.

(e) System Performance Evaluations

(1) Performance evaluations of the CT x-ray
system shall be performed by, or under the general supervision of, a CT QE who
assumes the responsibility for the evaluation.

(2) The performance evaluation of a CT x-ray
system shall be performed within 30 days of installation and at least every 14
months.

(3) Performance evaluation standards and
tolerances shall meet manufacturer's specifications or standards and tolerances
for the CT x-ray system from the American College of Radiology (ACR) and the
American Association of Physicists in Medicine (AAPM) incorporated herein by
reference including subsequent amendments and editions. These standards and tolerances
may be found at no charge on the ACR website at https://www.acr.org and the
AAPM website at www.aapm.org.

(4) The performance evaluation shall include
the following as applicable to the design of the scanner:

(G) a review of the results of the routine QC, as set
forth in Paragraph (f) of this Rule;

(5) The performance evaluation shall also
include the evaluation of radiation output and patient dose indices for the
following clinical protocols if performed:

(A) pediatric head;

(B) pediatric abdomen;

(C) adult head;

(D) adult abdomen; and

(E) brain perfusion.

(6) Evaluation of radiation output shall be
performed with a dosimetry system that is calibrated. The dosimetry system
shall have been calibrated within the preceding two years by persons registered
to provide such services pursuant to Rule .0205 of this Chapter.

(7) The performance evaluation shall be
documented and maintained for inspection by the Agency. The documentation shall
include the name of the CT QE performing or supervising the evaluation, as well
as any other individuals participating in the evaluation under the general
supervision of the CT QE. The documentation shall be retained for 14 months.

(f) Routine Quality Control (QC)

(1) A routine QC program for the CT system
shall be developed by or have written approval by a CT QE and include:

(A) instructions for the routine QC;

(B) intervals for QC testing;

(C) acceptable tolerances for the QC tests;

(D) use of a water equivalent phantom to evaluate each
day of clinical use: noise, CT number accuracy, and artifacts; and

(E) routine QC tests that may be performed in place of
system performance evaluations after equipment repairs or maintenance. This
shall include the process for obtaining approval from the CT QE prior to
conducting testing.

(2) The duties in the routine QC program, as
described in Subparagraph (f)(1) of this Rule, shall be conducted by
individuals that meet the requirements of Parargraph (d) of this Rule or
individuals approved by the CT QE.

(3) The routine QC shall be documented and
maintained for inspection by the Agency. The records shall be retained for 14
months.

(g) Operating Requirements. The following information shall
be accessible to the CT operator during use of the machine and while performing
routine QC:

(1) instructions on performing routine QC;

(2) a schedule of routine QC;

(3) any allowable variations set by the CT QE
for the indicated parameters;

(4) the results of the most recent routine QC
completed on the system; and

The provisions of this Section apply to all licensees who
use sealed sources in the healing arts and are in addition to, and not in
substitution for, other applicable provisions of the rules of this Chapter.

(1) Each licensee shall provide accountability
of sealed sources and shall keep a record of the issue and return of all sealed
sources. A physical inventory shall be made at least quarterly and a written
record of the inventory maintained.

(2) When not in use, sealed sources and
applicators containing sealed sources shall be kept in a protective enclosure
of such material and wall thickness as necessary to assure compliance with the
provisions of Rules .1604, .1609 and .1611 of this Chapter.

(b) Testing sealed sources for leakage and contamination

(1) All sealed sources with a half‑life
greater than 30 days and in any form other than gas shall be tested for leakage
and contamination prior to initial use and at intervals not to exceed six
months or at other intervals approved by the U.S. Nuclear Regulatory Commission
or an Agreement State in the Sealed Source and Device Registry. If there is
reason to suspect that a sealed source might have been damaged, or might be
leaking, it shall be tested for leakage before further use.

(2) Leak tests shall be capable of detecting
the presence of 0.005 microcurie of radioactive material on the test sample, or
in the case of radium, the escape of radon at rate of 0.001 microcurie per 24
hours. Any test conducted pursuant to Subparagraph (b)(1) of this Rule which
reveals the presence of 0.005 microcurie or more of removable contamination or,
in the case of radium, the escape of radon at the rate of 0.001 microcurie or
more per 24 hours shall be considered evidence that the sealed source is
leaking. The licensee shall immediately withdraw the source from use and shall
cause it to be decontaminated and repaired or to be disposed of in accordance
with applicable provisions of Section .1600 of this Chapter. A report
describing the sealed sources involved, the test results and the corrective
action taken shall be submitted in writing to the agency at the address stated
in Rule .0111 of this Chapter within five days after the test.

(3) Leak test results shall be recorded in
units of microcuries and maintained for inspection by the agency.

(c) Radiation surveys

(1) Immediately after implanting sources in an
individual the licensee shall make a radiation survey of the individual and the
area of use to confirm that no source has been misplaced. The licensee shall
make a record of each survey.

(2) Immediately after removing the last
temporary implant source from an individual, the licensee shall make a
radiation survey of the individual with a radiation detection survey instrument
to confirm that all sources have been removed. The licensee may not release
from confinement for medical care an individual treated by temporary implant
until all sources have been removed.

(d) A licensee shall maintain accountability for all
brachytherapy sources in storage or in use. After removing sources from an
individual, a licensee shall return brachytherapy sources to the storage area.
A licensee shall ensure that all sources taken from the storage area have been
returned, and shall make a record of the source accountability and retain the
record for three years.

(e) For temporary implants, the record shall include:

(1) the number and activity of sources removed
from storage;

(2) the date and time the sources were removed
from storage;

(3) the name of the individual who removed the
sources from storage;

(4) the location of use;

(5) the number and activity of sources returned
to storage;

(6) the date and time the sources were returned
to storage; and

(7) the name of the individual who returned the
sources to storage.

(f) For permanent implants, the record shall include:

(1) the number and activity of sources removed
from storage;

(2) the date and time the sources were removed
from storage;

(3) The name of the individual who removed the
sources from storage;

(4) the number and activity of sources not
implanted;

(5) the date the sources were returned to
storage; and

(6) the name of the individual who returned the
sources to storage.

(g) For each patient or human research subject who is
receiving brachytherapy and cannot be released under Rule .0358 of this
Section, a licensee shall:

(1) Not quarter the patient or human research
subject in the same room as an individual who is not receiving brachytherapy;

(2) Visibly post the patient's or human
research subject's room with a "Radioactive Materials" sign; and

(3) Note on the door or in the patient's or
human research subject's chart where and how long visitors may stay in the
patient's or human research subject's room.

(h) A licensee shall have applicable emergency response
equipment available near each treatment room to respond to a source;

(1) Dislodged from the patient; or

(2) Lodged within the patient following removal
of the source applicators.

(i) A licensee shall notify the Radiation Safety Officer or
his or her designee, and an authorized user as soon as possible if the patient
or human research subject has a medical emergency or dies.

(a) This Section provides special requirements for use of
ionizing radiation generating devices (RGDs) operating above five thousand
electron volts (5 keV), but below one million electron volts (1 MeV) that are
in addition to requirements in the other sections of this Chapter.

(b) This Section does not pertain to radiation safety
requirements for x-ray equipment that is covered in other sections of this
Chapter (e.g., x-rays in the healing arts in Section .0600 of this Chapter, and
particle accelerators in Section .0900 of this Chapter).

(5) "Certified bomb technician" means a
member of an accredited bomb squad who has completed the FBI Hazardous Devices
School. Information pertaining to this program can be found on the school
website at http://www.fbi.gov/about-us/cirg/hazardous-devices.

(6) "Certifiable cabinet x-ray system" means
an existing uncertified RGD that has been modified to meet the certification
requirements specified in 21 CFR 1020.40 as incorporated by reference in Rule
.0117 of this Chapter.

(7) "Certified cabinet x-ray system" means an
RGD utilized in an enclosed, interlocked cabinet, such that the radiation
machine will not operate unless all openings are securely closed. These systems
shall be certified in accordance with 21 CFR 1010.2 as incorporated by
reference in Rule .0117 of this Chapter, as being manufactured and assembled
pursuant to the provisions of 21 CFR 1020.40 as incorporated by reference in
Rule .0117 of this Chapter.

(8) "Collimator" means a device or mechanism
by which the x-ray beam is restricted in size.

(9) "Control panel" means that part of the
x-ray control upon which are mounted the switches, knobs, pushbuttons, and
other hardware necessary for manually setting the technique factors.

(11) "Enclosed beam RGD" means an RGD with all
possible x-ray beam paths contained in a chamber, coupled chambers, or other
beam-path-confinement devices to prevent any part of the body from intercepting
the beam during normal operations. Normal access to the primary beam path, such
as a sample chamber door, shall be interlocked with the high voltage of the
x-ray tube or the shutter for the beam to be considered "enclosed."
An open-beam device placed in an interlocked enclosure is considered an "enclosed
beam" unless there are provisions for routine bypassing of the interlocks.

(12) "Fail-safe characteristics" means a design
feature that causes the radiation beam to terminate, port shutters to close, or
otherwise prevents emergence of the primary beam, upon the failure of a safety
or warning device. For example, if an "X-ray On" light indicator or
shutter indicator or interlock fails, the radiation beam shall terminate.

(13) "Hand-held x-ray system" means any device
or equipment that is portable and used for similar purposes as analytical RGD
equipment.

(15) "Industrial radiography" means RGDs used
to make radiographic images to examine the structure of materials by
nondestructive methods. These RGDs shall not be contained in a cabinet and are
not permanent installations.

(16) "Ion implantation equipment, low-energy"
means any closed device operating below 1MeV used to accelerate elemental ions
and implant them in other materials.

(B) scatter radiation emanating from other
components (e.g., shutter or collimator); and

(C) radiation produced when the beam on switch or
timer is not activated.

(18) "Local components" means part of an RGD
x-ray system and include areas that are struck by x-rays such as radiation
source housings, port and shutter assemblies, collimators, sample holders,
cameras, goniometers, detectors, and shielding, but do not include power
supplies, transformers, amplifiers, readout devices, and control panels.

(19) "Mobile RGD" means RGD equipment mounted
on a permanent base with wheels or casters for moving while assembled.

(21) "Open-beam RGD" means a device or system
designed in such a way that the primary beam is not completely enclosed during
normal operation and used for analysis, gauging, or imaging in which an
individual could accidentally place some part of their body in the primary beam
or stray radiation path during normal operation.

(22) "Permanent radiographic installation"
means an RGD utilized in an enclosed shielded room, cell, or vault that allows
entry when the RGD is not energized.

(23) "Portable RGD" means RGD equipment
designed to be carried.

(24) "Primary beam" means radiation that passes
through an aperture of the source assembly housing by a direct path from the
radiation source.

(25) "Radiation generating device (RGD)" means
any system, device, subsystem, or machine component that may generate by
electronic means x-rays or particle radiation above 5 keV, but below 1 MeV, and
not used for healing arts on humans or animals. Examples of RGDs are the
following:

(A) analytical RGD equipment;

(B) certified and certifiable cabinet x-ray
systems;

(C) gauging devices using x-ray sources;

(D) hybrid gauging devices;

(E) e-beam welders;

(F) baggage scanners;

(G) industrial radiography RGDs; and

(H) permanent radiographic installations.

(26) "Remote components" means parts of an RGD
x-ray system that are not struck by x-rays such as power supplies,
transformers, amplifiers, readout devices, and control panels.

(27) "Scattered radiation" means radiation,
other than leakage radiation, that during passage through matter, has been
deviated in direction or has been modified by a decrease in energy.

(28) "Shutter" means an adjustable device,
generally made of lead or other high atomic number material, fixed to a source
assembly housing to intercept, block, or collimate the primary beam.

(29) "Source" means the point of origin of the
radiation, such as the focal spot of an x-ray tube.

(30) "Stationary RGD" means RGD equipment that
is installed or placed in a fixed location.

(31) "Stray radiation" means the sum of leakage
and scatter radiation emanating from the source assembly or other components
except for the primary beam, and radiation produced when the beam on switch or
timer is not activated.

(32) "X-ray generator" means the part of an
x-ray system that provides the accelerating (high) voltage and current for the
x-ray tube.

(33) "X-ray gauge" means an x-ray producing
device designed and manufactured for the purpose of detecting, measuring,
gauging, or controlling thickness, density, level, or interface location of
manufactured products.

(a) Certified cabinet x-ray systems shall meet the
requirements of 21 CFR 1020.40 as incorporated by reference in Rule .0117(a)(3)
of this Chapter.

(b) All certified and certifiable cabinet x-ray systems
shall:

(1) be constructed so that, the radiation
emitted from the system shall not exceed an exposure of 0.5 milliroentgen (mR)
in one hour at any point five centimeters outside the external surface; and

(2) have a fail-safe interlock that prevents
irradiation when the cabinet, chamber, or coupled chambers are open.

(c) Open-beam analytical RGD systems shall be equipped with
a safety device that prevents the entry of any portion of an individual's body
into the primary x-ray beam path that causes the beam to be shut off upon entry
into its path.

(1) x-ray tube status (ON‑OFF) located
near the radiation source housing, if the primary beam is controlled in this
manner; or

(2) shutter status (OPEN‑CLOSED) or beam
status (ON-OFF) located near each port on the radiation source housing, if the
primary beam is controlled in this manner.

(e) Warning devices on open-beam analytical RGDs shall be
labeled so that their purpose is identified. On open-beam analytical RGDs
installed after February 1, 1980, warning devices and lights shall have
fail-safe characteristics.

(f) Unused ports on radiation source housings for open-beam
RGDs shall be secured in the closed position in a manner that will prevent
unintended opening.

(g) Each port on the radiation source housing on open‑beam
analytical RGDs installed after February 1, 1980 and designed to accommodate
interchangeable components shall be equipped with a shutter that cannot be
opened unless a collimator or a component coupling is connected to the port.

(h) Portable open-beam analytical RGDs that shall be
manufactured to be used hand-held without safety devices are exempt from the
requirements of Paragraph (c) of this Rule and shall be constructed according
to International Standard IEC 62495 that is incorporated by reference and
includes subsequent amendments. This standard can be downloaded for one hundred
twenty-one dollars ($121.00) at the following website:
http://webstore.ansi.org/FindStandards.aspx?SearchString=IEC+62495+Ed.+1.0+en%3a2011&SearchOption=0&PageNum=0&SearchTermsArray=null%7cIEC+62495+Ed.+1.0+en%3a2011%7cnull.

(i) A registrant may apply to the agency, as defined in
Rule .0104 of this Chapter, for an exemption from the requirement of a safety
device. This request shall include:

(1) a description of the safety devices;

(2) the reason safety devices cannot be used;
and

(3) a description of the alternative methods
that will be employed to minimize the possibility of an accidental exposure,
including procedures to assure that operators and others in the area will be
informed of the absence of safety devices.

(j) Analytical RGDs shall be provided with a visible and
legible label(s) bearing the radiation symbol and the words:

(1) "CAUTION ‑ HIGH INTENSITY X-RAY
BEAM," or words having a similar meaning, near the exit port to identify
the location of the beam; and

(2) "CAUTION ‑ RADIATION ‑
THIS EQUIPMENT PRODUCES RADIATION WHEN ENERGIZED", or words having a
similar meaning, near any switch that energizes an x-ray tube, if the radiation
source is an x-ray tube.

(k) Warning lights labeled with the words "X-RAYS
ON," or other words having similar meaning, shall be located:

(1) near any switch that activates the high
voltage to energize an x-ray tube; or

(2) in a conspicuous location near the
radiation source housing and radiation beam(s) and visible from all instrument
access areas.

(l) Warning lights shall activate when the x-ray tube is
energized.

(m) Each x-ray tube housing shall be:

(1) constructed that when all shutters are
closed the leakage radiation measured at a distance of five centimeters from
its surface is not capable of producing an exposure in excess of 2.5 millirem
(mrem)/ (25 microsieverts µSv) in one hour; and

(2) if the tube housing is the primary
shielding for the x-ray tube, does not produce x-rays when the housing is
opened or disassembled.

(n) Each x-ray generator shall be supplied with a
protection cabinet which limits leakage radiation measured at a distance of
five centimeters from its surface such that it is not capable of producing an
exposure in excess of 0.25 mrem/2.5µSv in one hour.

(o) Permanent radiographic installations and industrial
radiography RGDs shall comply with the requirements of Rule .0807 of this
Section.

(a) The local components of RGDs shall be located and
arranged to include sufficient shielding or access control to ensure no
radiation levels exist in any area surrounding the local components that could
result in a dose to an individual present in excess of the dose limits given in
Rule .1611(a) of this Chapter.

(b) Survey Requirements

(1) Radiation surveys, as set forth in Rule
.1613(a) and (b) of this Chapter, of all RGDs sufficient to show compliance
with Paragraph (a) of this Rule, shall be performed:

(A) within 30 days after initial operation of the
device;

(B) prior to use following any change in the initial
arrangement, including the number or type of local components in the system; and

(C) prior to use following any maintenance requiring the
disassembly or removal of a local component in the system that could affect the
radiation exposure to personnel.

(2) A registrant may apply to the agency for
approval of procedures differing from those in Subparagraph (b)(1) of this
Rule, provided that the registrant demonstrates satisfactory compliance with
Paragraph (a) of this Rule.

(3) Surveys shall be performed with a radiation
survey instrument capable of the following:

(A) measuring the radiation energies of the system
surveyed;

(B) confirming that the radiation limits of this Section
are met; and

(C) calibrated according to the manufacture's
recommended frequency or at least annually when a frequency is not recommended.

(c) Each area of use or room containing RGDs shall be
conspicuously posted with caution signs in accordance with the requirements of
Rule .1623 of this Chapter, bearing the radiation caution symbol and the words
"CAUTION ‑ X-RAY EQUIPMENT," or words having a similar meaning.

(a) RGDs shall be operated by individuals that have
completed the training requirements of Rule .0806 of this Section.

(b) Normal operating procedures shall be written and
available to all RGD operators and support staff.

(c) No individual shall be permitted to operate RGDs in any
manner other than that specified in the operating procedures unless the person
has obtained written approval of the individual responsible for radiation or
the Radiation Safety Officer (RSO) as defined in Rule .0104 of this Chapter.

(d) No individual shall bypass a safety device unless the
person has obtained the approval of the person responsible for radiation safety
or the RSO. This process shall be incorporated into the radiation protection
program by the RSO, as set forth in Rule .1603(a), and the operating procedures
as set forth in Rule .0603(a)(1)(B). The written approval, as granted by the
RSO, shall include an expiration date. When a safety device has been bypassed,
a legible sign bearing the words "SAFETY DEVICE NOT WORKING" or words
having a similar meaning shall be placed on the radiation source housing and
the control panel during the bypassing period.

the individual shall determine the tube is off and will
remain off until safe conditions have been restored.

(f) Safety devices including interlocks, shutters, and
warning lights shall be tested once annually for proper operation on all RGDs
in operation. Records of the testing shall be retained by the registrant for three
years.

(g) No individual shall hold a sample or object while it is
being irradiated.

(1) No person shall be permitted to operate or
maintain RGDs unless the person has received instruction in the operating and
emergency procedures for the RGD and instruction that is in accordance with
Rule .1003 of this Chapter.

(2) Each registrant operating or maintaining
RGDs shall maintain, for inspection by the agency, records of training that demonstrate
the requirements of this Rule have been satisfied.

(a) Permanent radiographic installations and industrial
radiography RGDs are exempt from the requirements of the rules of this Section
except Rule .0802 and Rule .0804(a), (b)(1)(A), (b)(1)(C), (b)(2), and (b)(3).

(b) Permanent radiographic installations and industrial
radiography RGDs shall comply with the following rules of this Chapter:

(1) .0501;

(2) .0502;

(3) .0506;

(4) .0509-.0520;

(5) .0522;

(6) .0523(a)(1);

(7) .0523(a)(3);

(8) .0523(a)(6) -.0523(a)(15);

(9) .0523(b)(1) -.0523(b)(4);

(10) .0523(b)(6) -.0523(b)(7);

(11) .0523(b)(9) -.0523(b)(12);

(12) .0523(c); and

(13) .0525.

History Note: Authority G.S. 104E‑7;

Eff. October 1, 2015.

10A NCAC 15 .0808 APPLICABLE RULES FOR BOMB DETECTION
RGDS

Bomb detection RGDs utilized by accredited bomb squads and
certified bomb technicians shall comply with the following rules of this
Chapter:

(1) .0501;

(2) .0502;

(3) .0509;

(4) .0511-.0520 except for the requirements for a
direct reading pocket dosimeter and operating alarm ratemeter in .0512(a);

(a) This Section establishes procedures for the licensing
and the use of particle accelerators.

(b) In addition to the requirements of this Section, all
licensees are subject to the requirements of Sections .0100, .0200, .1000, and
.1600 of this Chapter. Licensees engaged in industrial radiographic operations
are subject to the requirements of Section .0500 of this Chapter, and licensees
engaged in the healing arts are subject to Rule .0350 of this Chapter and the
applicable requirements of Section .0600 of this Chapter. Licensees engaged in
the production of radioactive material or possessing radioactive material
incidental to an accelerator are subject to the requirements of Section .0300
of this Chapter.

(c) In addition to the requirements of this Section, all
particle accelerator licensees are subject to the annual fee provisions
contained in Section .1100 of this Chapter.

No person shall receive, possess, use, transfer, own, or
acquire a particle accelerator except as authorized in a license issued
pursuant to these Rules or as otherwise provided for in these Rules. The
general procedures for licensing of particle accelerator facilities are
included in Section .0903 of this Chapter.

10A NCAC 15 .0903 REQUIREMENTS FOR ISSUANCE OF A LICENSE
FOR ACCELERATORS

Application for use of a particle accelerator will be
approved only if the agency determines that:

(1) The applicant and his operators are qualified by
reason of training and experience to use the accelerator in such a manner as to
minimize danger to public health and safety or property;

(2) The applicant's proposed equipment, facilities,
operating and emergency procedures are adequate to protect health and minimize
danger to public health and safety or property;

(3) The applicant has appointed a radiation safety
officer;

(4) The applicant has established a radiation safety
committee to approve that the operation of the particle accelerator is in
accordance with applicable radiation protection Sections of this Chapter; and

(5) The applicant for the use of a particle accelerator
in the healing arts shall be a physician licensed to practice medicine in the
state of North Carolina. The individuals designated on the application as users
shall have substantial training and experience in deep therapy techniques or in
the use of particle accelerators to treat humans.

(a) No licensee shall permit any person to act as a
particle accelerator operator until such person:

(1) has been instructed in radiation safety and
shall have demonstrated an understanding thereof;

(2) has received copies of, and instruction in,
this Section and the applicable requirements of this Chapter, pertinent
licensing conditions and the licensee's operating and emergency procedures; and

(3) has demonstrated competence to use the
particle accelerator, related equipment, and survey instruments which will be
employed in his assignment.

(b) Either the radiation safety committee or the radiation
safety officer shall have the authority to terminate the operations at a
particle accelerator facility if this action is deemed necessary to minimize
danger to public health and safety or property.

(a) A qualified expert registered by the agency pursuant to
Rule .0205 of this Chapter, shall be consulted in the design of a particle
accelerator installation. A qualified expert shall perform a radiation survey
when the accelerator is first capable of producing radiation to verify that
radiation levels and shielding effectiveness meet the applicable requirements
in this Chapter. A copy of the survey shall be submitted to the agency by the
licensee prior to its use for its licensed purpose.

(b) Plans for construction of accelerator installations
shall be submitted to the agency.

(c) Each particle accelerator installation shall be
provided with such primary and secondary barriers as are necessary to assure
compliance with Rules .1604 and .1611 of this Chapter.

(a) Instrumentation, readouts and controls on the particle
accelerator control console shall be clearly identified and easily discernible.

(b) All entrances into a target room or other high
radiation area shall conform to the requirements of Rule .1615 of this Chapter.

(c) When an interlock system has been tripped, it shall
only be possible to resume operation of the accelerator by manually resetting
controls at the position where the interlock has been tripped and, subsequently
at the main control console.

(d) Each safety interlock shall operate independently of
all other safety interlocks.

(e) All safety interlocks shall be fail‑safe, i.e.,
designed so that any defect or component failure in the interlock system
prevents operation of the accelerator.

(f) A "Scram button" or other emergency power cut‑off
switch shall be located and easily identifiable in all high radiation areas and
at the control console. Such a cut‑off switch shall include a manual reset
so that the accelerator cannot be restarted from the accelerator control
console without first manually resetting the cut‑off switch.

(a) All locations designated as high radiation areas, and
entrances to such locations shall be equipped with easily observable warning
lights that operate when, and only when, radiation is being produced.

(b) Except in facilities designed for human exposure, each
high radiation area shall have an audible warning device which shall be
activated for 15 seconds prior to the possible creation of such high radiation
area. This warning device shall be clearly discernible in all high radiation
areas and all radiation areas.

(c) Barriers, temporary or otherwise, and pathways leading
to high radiation areas shall be identified in accordance with Rule .1624 of
this Chapter.

(a) Particle accelerators, when not in operation, shall be
secured to prevent unauthorized use.

(b) Only a switch on the accelerator control console shall
be routinely used to turn the accelerator beam "on" and "off".
The safety interlock system shall not be used to turn off the accelerator beam
except in an emergency.

(c) All safety and warning devices, including interlocks
shall be checked for proper operability at least every six months unless more
frequent checks are required by the agency. Results of such tests shall be
maintained for two years at the accelerator facility for inspection by the
agency.

(d) Electrical circuit diagrams of the accelerator, and the
associated interlock systems, shall be kept current and maintained for
inspection by the agency.

(e) If, for any reason, it is necessary to intentionally
bypass a safety interlock or interlocks, such action shall be:

(1) authorized by the radiation safety officer;

(2) recorded in a permanent log and a notice
posted at the accelerator control console and at the location of the bypassed
interlock; and

(3) terminated as soon as possible.

(f) A copy of the current operating and the emergency
procedures shall be maintained at the accelerator control panel.

(a) Portable monitoring equipment shall be available at
each particle accelerator facility. Such equipment shall be tested for proper
operation monthly and calibrated at intervals not to exceed one year, and after
each servicing and repair.

(b) A radiation protection survey shall be performed and
documented by a qualified expert registered by the agency pursuant to Rule
.0205 of this Chapter, when changes have been made in shielding, operation,
equipment, or occupancy of adjacent areas. The licensee shall submit the
report of the qualified expert to the agency at the address found in Rule .0111
of this Chapter.

(c) Except for facilities designed for human exposure,
radiation levels in all high radiation areas shall be continuously monitored.
The monitoring devices shall be electrically independent of the accelerator
control and interlock systems and capable of providing a remote and local
readout with visual or audible alarms at the control panel and other
appropriate locations.

(d) All area monitors shall be tested for proper operation
at least every six months unless more frequent checks are required by the
agency.

(e) Whenever applicable, periodic surveys shall be made to
determine the amount of airborne particulate radioactivity present in areas of
airborne hazards.

(f) Whenever applicable, periodic smear surveys shall be
made to determine the degree of contamination in target and other pertinent
areas.

(g) All area surveys shall be made in accordance with the
written procedures established by a qualified expert registered by the agency
pursuant to Rule .0205 of this Chapter, or the radiation safety officer of the
particle accelerator facility.

(h) Records of all radiation protection surveys,
calibration results, instrumentation tests, and smear results shall be kept
current and on file at each accelerator facility for two years for inspection
by the agency.

This Section establishes requirements for notices,
instructions and reports by licensees or registrants to individuals engaged in
work under a license or registration and options available to such individuals
in connection with agency inspections of licensees or registrants to ascertain
compliance with the provisions of the Act and rules, orders and licenses issued
thereunder regarding radiological working conditions. The rules in this
Section apply to all persons who receive, possess, use, own or transfer sources
of radiation licensed by or registered with the agency pursuant to the rules in
Sections .0200, .0300, .0900 and .1200 of this Chapter.

(a) Each licensee or registrant shall post current copies
of the following documents:

(1) the rules in this Section and in Section
.1600 of this Chapter;

(2) the license, certificate of registration, conditions
or documents incorporated into the license by reference and amendments thereto;

(3) the operating procedures applicable to work
under the license or registration;

(4) any notice of violation involving
radiological working conditions, any order issued pursuant to Section .0100 of
this Chapter and any response from the licensee or registrant.

(b) If posting of a document specified in Subparagraphs
(a)(1), (2) or (3) of this Rule is not practicable, the licensee or registrant
may post a notice which describes the document and states where it may be
examined.

(c) The agency form "Notice to Employees" shall
be posted by each licensee or registrant wherever individuals work in or
frequent any portion of a restricted area.

(d) The agency form "Notice to Employees"
contains information to employees regarding employer's responsibility, worker's
responsibility, the subjects covered by this Section, reports on radiation
exposure history, inspections, and any other information that the agency may
include.

(e) Documents, notices or forms posted pursuant to this
Rule shall appear in a sufficient number of places to permit individuals
engaged in work under the license or registration to observe them on the way to
or from any particular work location to which the document applies, shall be
conspicuous, and shall be replaced if defaced or altered.

(f) Agency documents posted pursuant to Subparagraph (a)(4)
of this Rule shall be posted within two working days after receipt of the
documents from the agency; the licensee's or registrant's response, if any,
shall be posted within two working days after dispatch from the licensee or
registrant. Such documents shall remain posted for a minimum of five working
days or until action correcting the violation has been completed, whichever is
later.

(a) All individuals who, in the course of employment, are
likely to receive in a year an occupational dose in excess of 100 millirem (1
millisievert) shall be kept informed of the storage, transfer, or use of radioactive
material or of radiation in such portions of the restricted area; shall be
instructed in the health protection problems associated with exposure to such
radioactive material or radiation, in precautions or procedures to minimize
exposure, and in the purposes and functions of protective devices employed;
shall be instructed in, and instructed to observe, to the extent within the
worker's control, the applicable provisions of this Chapter and licenses for
the protection of personnel from exposures to radiation or radioactive
material occurring in such areas; shall be instructed of their responsibility
to report promptly to the licensee or registrant any condition which may lead
to or cause a violation of rules in this Chapter and licenses or unnecessary
exposure to radiation or radioactive material; shall be instructed in the
appropriate response to warnings made in the event of any unusual occurrence or
malfunction that may involve exposure to radiation or radioactive material; and
shall be advised as to the radiation exposure reports which workers may request
pursuant to Rule .1004 of this Section. The extent of these instructions shall
be commensurate with potential radiological health protection problems in the
restricted area.

(b) In determining those individuals subject to the
requirements of Paragraph (a) of this Rule, licensees or registrants shall take
into consideration assigned activities during normal and abnormal situations
involving exposure to all sources of radiation and radioactive material which
can reasonably be expected to occur during the life of the licensed or
registered facility. The extent of these instructions shall be commensurate
with the potential radiological health protection problems present in the
workplace.

(a) Licensees and registrants shall report radiation
exposure data for any occupationally exposed person to that person or their
designee in accordance with the provisions of 10 CFR 19.13, except that the
report shall contain the following statement in lieu of the statement appearing
in 19.13(a): "This report is furnished to you under the provisions of 10A
NCAC 15 Section .1000: NOTICES: INSTRUCTIONS: REPORTS AND INSPECTIONS. You
should preserve this report for future reference."

(b) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

(a) Each licensee or registrant shall afford to the agency
at all reasonable times opportunity to inspect radioactive materials, radiation
machines, activities, facilities, premises, and records required to be
maintained by provisions of this Chapter.

(b) During an inspection, agency inspectors may consult
privately with workers as specified in Rule .1006 of this Section. The
licensee or registrant may accompany agency inspectors during other phases of
an inspection.

(c) If, at the time of inspection, an individual has been
authorized by the workers to represent them during agency inspections, the
licensee or registrant shall notify the inspectors of such authorization and
shall give the workers' representative an opportunity to accompany the
inspectors during the inspection of physical working conditions.

(d) Each workers' representative shall be routinely engaged
in work under control of the licensee or registrant and shall have received
instructions as specified in Rule .1003 of this Section.

(e) Different representatives of licensees or registrants
and workers may accompany the inspectors during different phases of an
inspection if there is no resulting interference with the conduct of the
inspection.

(f) A consultant or representative to the licensee,
registrant, or workers shall be afforded the opportunity to accompany the
agency inspectors during the inspection of physical working conditions.

(g) Notwithstanding the other provisions of this Rule,
agency inspectors are authorized to refuse to permit accompaniment by any
individual who deliberately interferes with a fair and orderly inspection.
With regard to any area containing proprietary information, the workers'
representative for that area shall be an individual previously authorized by
the licensee or registrant to enter that area.

(a) Agency inspectors may consult privately with workers
concerning matters of occupational radiation protection and other matters
related to applicable provisions of this Chapter and licenses to the extent the
inspectors deem necessary for the conduct of an effective and thorough
inspection.

(b) During the course of an inspection any worker may bring
privately to the attention of the inspectors, either orally or in writing, any
past or present condition which he has reason to believe may have contributed
to or caused any violation of the Act, provisions of this Chapter, or license
condition, or any unnecessary exposure of an individual to radiation from
licensed radioactive material or a registered radiation machine under the
licensee's or registrant's control. Any such notice in writing shall comply
with the requirements of Rule .1007 of this Section.

(c) The provisions of Paragraph (b) of this Rule shall not
be interpreted as authorization to disregard instructions pursuant to Rule
.1003 of this Section.

(a) Any worker or representative of workers who believes
that a violation of the Act, provisions of this Chapter or license conditions
exists or has occurred in work under a license or registration with regard to
radiological working conditions in which the worker is engaged, may request an
inspection by giving notice of the alleged violation to the Director of the
Division of Radiation Protection, P.O. Box 27687, Raleigh, North Carolina
27611‑7687. Any such notice shall be in writing, shall set forth the
specified grounds for the notice, and shall be signed by the worker or
representative of the workers. A copy shall be provided to the licensee or
registrant by the Director of the Division of Radiation Protection no later
than at the time of inspection except that, upon request of the worker giving
such notice, his name and the name of individuals referred to therein shall not
appear in such copy or on any record published, released, or made available by
the agency, except for good cause shown.

(b) If, upon receipt of such notice, the Director of the
Division of Radiation Protection determines that the complaint meets the
requirements set forth in Paragraph (a) of this Rule and that there are
reasonable grounds to believe that the alleged violation exists or has
occurred, he shall cause an inspection to be made as soon as practicable, to
determine if such alleged violation exists or has occurred. Inspections
pursuant to this Rule need not be limited to matters referred to in the
complaint.

(c) No licensee or registrant shall discharge or in any
manner discriminate against any worker because such worker has filed any
complaint or instituted or caused to be instituted any proceeding under this
Chapter or has testified or is about to testify in any such proceeding or
because of the exercise by such worker on behalf of himself or others of any
option afforded by this Section.

(a) If the Director of the Division of Radiation Protection
determines, with respect to a complaint under Rule .1007 of this Section that
an inspection is not warranted because there are no reasonable grounds to
believe that a violation exists or has occurred, the Director of the Division
of Radiation Protection shall notify the complainant in writing of such
determination. The complainant may obtain review of such determination by
submitting a written statement of position with the Secretary, Department of
Environment, Health, and Natural Resources, P.O. Box 27687, Raleigh, North
Carolina 27611‑7687, who will provide the licensee or registrant with a
copy of such statement by certified mail, excluding, at the request of the
complainant, the name of the complainant. The licensee or registrant may
submit an opposing written statement of position with the Secretary, Department
of Environment, Health, and Natural Resources who will provide the complainant
with a copy of such statement by certified mail. Upon the request of the
complainant, the Secretary, Department of Environment, Health, and Natural
Resources may hold an informal conference in which the complainant and the
licensee or registrant may orally present their views. An informal conference
may also be held at the request of the licensee or registrant, but disclosure
of the identity of the complainant will be made only following receipt of
written authorization from the complainant. After considering all written or
oral views presented, the Secretary, Department of Environment, Health, and
Natural Resources shall affirm, modify, or reverse the determination of the
Director of the Division of Radiation Protection and furnish the complainant
and the licensee or registrant a written notification of his decision and the
reason therefor.

(b) If the Director of the Division of Radiation Protection
determines that an inspection is not warranted because the requirements of Rule
.1007(a) of this Section have not been met, he shall notify the complainant in
writing of such determination. Such determination shall be without prejudice
to the filing of a new complaint meeting the requirements of Rule .1007(a) of
this Section.

(a) This Section establishes annual fees to cover the
anticipated costs of inspection, educational and training activities of the
agency.

(b) The fees are imposed on persons registered pursuant to
provisions of Section .0200 of this Chapter, on persons licensed pursuant to
provisions of Sections .0300 and .0900 of this Chapter, and on certain persons
applying for out‑of‑state reciprocal recognition.

(c) Notwithstanding Paragraph (b) of this Rule, no fee
shall be imposed on any person in conjunction with the person's possession and
use of any luminous safety device or luminous gunsight pursuant to the general
licenses in Rules .0309 and .0311 of this Chapter. For purposes of this
Section, "luminous safety device" means an exit marker, hazard
warning sign, safety related marker, or other safety equipment containing one
or more radioactive material powered light sources for the purpose of improving
legibility or visibility.

(a) All fees established in this Section shall be due on
the first day of July of each year.

(b) Notwithstanding Paragraph (a) of this Rule, when a new
license or registration is issued by the agency after the effective date of
this Rule or after the first day of July of any subsequent year, the initial
fee shall be due on the date of issuance of the license or registration.

(c) The initial fee in Paragraph (b) of this Rule shall be
computed as follows:

(1) When any new license or registration is
issued before the first day of January of any year, the initial fee shall be
the full amount specified in Rule .1105 or .1106 of this Section; and

(2) When any new license or registration is
issued on or after the first day of January of any year, the initial fee shall
be one-half of the amount specified in Rule .1105 or .1106 of this Section.

(d) All fees received by the agency pursuant to provisions
of this Section shall be nonrefundable.

(e) Each licensee or registrant shall pay all fees by check
or money order made payable to "Radiation Protection Section" and
mail such payment to: Radiation Protection Section, Division of Environmental
Health, Department of Environment and Natural Resources, 1645 Mail
Service Center, Raleigh, North Carolina 27699-1645. Such payment may be
delivered to the agency at its office located at 3825 Barrett Drive, Raleigh,
North Carolina 27609-7221.

History Note: Authority G.S. 104E-9(a)(8); 104E-19(a);

Eff. July 1, 1982;

Amended Eff. May 1, 1993; May 1, 1992; July 1, 1989;

Temporary Amendment Eff. June
30, 2002;

Temporary Amendment Expired on March 28, 2003;

Findings of need for Emergency Rule disapproved by
Codifier on June 8, 2007;

Within five days after the due dates established in
Paragraphs (a) and (b) of Rule .1102 of this Section, the agency shall mail to
each licensee and registrant, who has not already submitted payment, a notice
which indicates the due date, delinquent date and the amount of fees due.

(a) Payment of fees established in this Section shall be
delinquent, if not received by the agency within 60 days after the due date
specified in Paragraphs (a) and (b) of Rule .1102 of this Section.

(b) If a licensee or registrant remits a fee in the form of
a check or other instrument which is uncollectible from the paying institution,
the agency shall notify the licensee or registrant by certified mail and allow
the licensee or registrant 15 days to correct the matter, which includes
payment of any fee charged to the agency by a banking institution.

(c) If payment of fees is uncollectible from the paying
institution or not submitted to the agency by the delinquent date, the agency
may institute legal action to collect.

(a) Annual fees for persons registered pursuant to
provisions of Section .0200 of this Chapter are as listed in the following
table:

Type of Registered

Facility

Letters Appearing in Registration Number

Facility Plus First

X-ray Tube

Each Additional

X-ray Tube

Chiropractors

C

$ 180.00

$ 24.00

Dentists

D

$ 180.00

$ 24.00

Educational

E

$ 130.00

$ 22.00

Government

G

$ 130.00

$ 22.00

Podiatrists

H

$ 180.00

$ 24.00

Industrial

I

$ 180.00

$ 24.00

Industrial Medical

IM

$ 260.00

$ 33.00

Health Departments

L

$ 260.00

$ 33.00

Hospitals

M

$ 390.00

$ 44.00

Physicians

P

$ 180.00

$ 24.00

Industrial Radiography

R

$ 380.00

$ 44.00

Services

S

$ 260.00

$ 0.00

Therapy

T

$ 400.00

$ 50.00

Veterinarians

V

$ 130.00

$ 22.00

Other

Z

$ 180.00

$ 24.00

(b) Annual fees for out-of-state persons granted permission
to use sources of radiation in this state pursuant to provisions of Rule .0211
of this Chapter are the same as that provided for in the applicable category
specified in Paragraph (a) of this Rule.

(b) Annual fees for persons licensed pursuant to provisions
of Section .0900 of this Chapter are as listed in the following table:

Type of Accelerator License Annual
Fee

-Medical (home office including 1
unit) $
2,000.00

-Medical (per additional unit) $
200.00

-Industrial/Manufacturing (home
office including 1 unit) $ 2,000.00

-Industrial/Manufacturing (per
additional unit) $ 200.00

-Sales, Service, Refurbishment,
Manufacture $ 2,000.00

(c) Annual fees for out-of-state persons granted permission
to use sources of radiation in this state pursuant to provisions of Rule .0345
of this Chapter are the same as that provided for in the applicable category
specified in Paragraphs (a) and (b) of this Rule. Such fees are due when
application for reciprocal recognition of out-of-state license or registration
is made in the same manner as for a new license or registration as specified in
Rule .1102.

(a) This Section establishes the procedures, criteria, and
terms and conditions upon which the agency issues licenses authorizing land
disposal of low‑level radioactive waste received from other persons for
disposal. Disposal of low‑level radioactive waste by the specific
licensee who generates such waste is subject to the provisions of Rule .1628 of
this Chapter.

(b) The rules in this Section do not apply to the disposal
of:

(1) low‑level radioactive waste which is
higher than Class C waste as defined in Rule .1628 of this Chapter;

(2) byproduct material as defined in Section
11e.(2) of the Atomic Energy Act of 1954, as amended, in quantities greater
than 10,000 kilograms and containing more than five millicuries of radium‑226;
or

(3) licensed radioactive material pursuant to
provisions of Rule .1628 of this Chapter.

(c) Nothing in this Section shall relieve any person of
responsibility for complying with other applicable North Carolina laws and
rules.

(d) This Section is designed to fulfill two objectives:

(1) to meet the requirement of compatibility
with the U.S. Nuclear Regulatory Commission regulations, and

(2) to provide general guidance for the design,
operation, closure and institutional control of a low‑level radioactive
waste disposal facility that has features to enhance its performance and
provide additional confidence in its integrity.

As described in 10 CFR Part 61, Section 61.7 Concepts, land
disposal is intended to further four safety objectives:

(1) protection of the public from releases of
radioactivity,

(2) protection of an inadvertent intruder,

(3) protection of workers at the facility, and

(4) assurance of long‑term stability
after closure. There is every indication in research reports and environmental
impact statements that land disposal with attention to site selection, waste
classification, waste form, segregation and stability will limit radiation
doses to those within the cited performance objectives of 10 CFR Part 61.
Supplementary engineered barriers are included in the rules for North Carolina,
however, to fulfill a further objective, viz,

(5) protection against the possibility of
unforeseen differences between expected and actual behavior of the disposal
system.

The five goals are to be sought through the design,
construction, and operation of a system that involves a carefully chosen
combination of features that are described in existing rules plus additional
requirements for engineered barriers. The total system will make use of
selected processes and structures, such as compaction, solidification,
packaging in high‑integrity containers, placement of wastes, use of
concrete for walls or fill, special trench covers, drainage systems, or other
devices. The facility design objectives are to minimize contact of water with
wastes, facilitate detection of water and contamination, retard release of
radioactive materials, suppress the migration of wastes in the geologic medium,
and accommodate timely recovery of wastes if necessary. Account is to be taken
of radiation dose limits for facility workers and the public, and efforts are
to be made to reduce costs without sacrificing safety.

The concept of "reasonable assurance" is used
throughout this Section. Reasonable assurance is to be understood as placing
primary emphasis on protection of public health and the environment. The cost
of achieving reasonable assurance will be only a secondary consideration.

(e) Persons licensed pursuant to the provisions of this
Section are also subject to the rules in Sections .0100, .0300, .1000, .1100,
and .1600 of this Chapter, except as provided otherwise in this Section.

(1) "Active maintenance" means any
significant remedial activity needed during the period of institutional control
to maintain a reasonable assurance that the performance objectives in Rules
.1223 and .1224 of this Section are met. Such active maintenance includes
ongoing activities such as the pumping and treatment of water from a disposal
unit or one‑time measures such as replacement of a disposal unit cover.
Active maintenance does not include custodial activities such as repair of
fencing, repair or replacement of monitoring equipment, revegetation, minor
additions to soil cover, minor repair of disposal unit covers, and general
disposal site upkeep such as mowing grass.

(2) "Buffer zone" is a portion of the
disposal site that is controlled by the licensee and that lies under the
disposal units and between the disposal units and the boundary of the site.

(4) "Commencement of construction" means
clearing of land, excavation, or other substantial action that would adversely
affect the environment of a land disposal facility. The term does not mean
disposal site exploration, necessary roads for disposal site exploration,
borings to determine foundation conditions, or other preconstruction monitoring
or testing to establish background information related to the suitability of
the disposal site or the protection of environmental values.

(6) "Disposal" means the isolation of waste
from the biosphere inhabited by man and his food chains by emplacement in a
land disposal facility.

(7) "Disposal site" means that portion of a
land disposal facility which is used for disposal of waste. It consists of
disposal units and a buffer zone.

(8) "Disposal system" means the components
relied on to ensure that the land disposal facility meets the performance
objectives and other requirements of this Section. These components include
the site and its characteristics, the facility and disposal unit design, and
engineered barriers therein, the waste, facility operations and closure,
intruder barriers and institutional control.

(9) "Disposal unit" means a discrete portion
of the disposal site into which waste is placed for disposal. For near‑surface
disposal, the disposal unit is usually a trench.

(11) "Explosive material" means any chemical
compound, mixture, or device, which produces a substantial instantaneous
release of gas and heat spontaneously or by contact with sparks or flame.

(12) "Government agency" means any executive
department, commission, independent establishment, or corporation, wholly or
partly owned by the United States of America or the State of North Carolina and
which is an instrumentality of the United States or the State of North
Carolina; or any board, bureau, department, division, service, office, officer,
authority, administration, or other establishment in the executive branch of
the government.

(13) "Hazardous waste" means those wastes
designated as hazardous by U.S. Environmental Protection Agency regulations in
40 CFR Part 261.

(14) "Hydrogeologic unit" means any soil or
rock unit or zone which by virtue of its porosity or permeability, or lack
thereof, has a distinct influence on the storage or movement of groundwater.

(15) "Inadvertent intruder" means a person who
might occupy the disposal site after closure and engage in normal activities,
such as agriculture, dwelling construction, or other pursuits in which the
person might be unknowingly exposed to radiation from the waste.

(16) "Intruder barrier" means a sufficient
depth of cover over the waste that inhibits contact with waste and helps to
ensure that radiation exposures to an inadvertent intruder will meet the
performance objectives set forth in this Section, or engineered structures that
provide equivalent protection to the inadvertent intruder.

(17) "Institutional control" means control of
the site after the site is closed and stabilized and responsibility for all
disposed waste and site maintenance is assumed by the custodial agency.

(19) "Low‑level radioactive waste" means
low‑level radioactive waste as defined in G.S. 104E‑5(9a) and
includes naturally occurring and accelerator produced radioactive material
which is not subject to regulation by the U.S. Nuclear Regulatory Commission
under the Atomic Energy Act of 1954, as amended, and is suitable for land
disposal under the provisions in this Section.

(20) "Mixed waste" means waste that satisfies
the definition of low‑level radioactive waste in Item (19) of this Rule
and contains hazardous waste that either:

(a) is listed as a hazardous waste in Subpart D
of 40 CFR Part 261 or

(b) causes the low‑level radioactive waste
to exhibit any of the hazardous waste characteristics identified in Subpart C
of 40 CFR Part 261.

(21) "Monitoring" means observing and making
measurements to provide data to evaluate the performance and characteristics of
the disposal site.

(22) "Near‑surface disposal facility"
means a land disposal facility in which waste is disposed of within
approximately the upper 30 meters of the earth's surface.

(23) "Reconnaissance level information" is any
information or analysis that can be retrieved or generated without the
performance of new comprehensive site‑specific investigations.
Reconnaissance level information includes but is not limited to drilling
records required by state agencies, other Divisions of this Department, and
other relevant published scientific literature.

(24) "Retrieval" means a remedial action for
removal of Class B and C waste from a disposal unit.

(25) "Shallow land burial" means shallow land
burial as defined in G.S. 104E‑5(14a).

(26) "Site closure and stabilization" means
those actions that are taken upon completion of operations that prepare the
disposal site for custodial care and that assure that the disposal site will
remain stable and will not need ongoing active maintenance.

(27) "State" means the State of North Carolina.

(28) "Surveillance" means monitoring and
observation of the disposal site for purposes of visual detection of need for
maintenance, custodial care, evidence of intrusion, and compliance with other
license and regulatory requirements.

(29) "Waste" means low‑level radioactive
waste that is acceptable for disposal in a land disposal facility. For the
purpose of this Section, the words "waste" and "low‑level
radioactive waste" have the same meaning.

(a) No person may receive, possess, and dispose of waste
from other persons at a land disposal facility unless authorized by a license
issued by the agency pursuant to the rules in this Section and the rules in
Section .0300 of this Chapter.

(b) Each person shall file an application with the agency
pursuant to Rule .0317 of this Chapter and obtain a license as provided in this
Section before commencement of construction of a land disposal facility.
Failure to comply with this requirement may be grounds for denial of a license.

An application for a license to receive waste from other
persons and possess and dispose of wastes containing or contaminated with
radioactive material by land disposal shall consist of general information, specific
technical information, environmental information, technical and environmental
analyses, institutional information, and financial information as set forth in
Rules .1205 through .1210 of this Section.

(A) the full name, address, telephone number, and
description of the business or occupation of the applicant;

(B) if the applicant is a partnership, the name and
address of each partner and the principal location where the partnership does
business;

(C) if the applicant is a corporation or an
unincorporated association,

(i) the state where it is incorporated or organized
and the principal location where it does business, and

(ii) the names and addresses of its directors and
principal officers;

(D) if the applicant is acting as an agent or
representative of another person in filing the application, all information required
under this Paragraph shall be supplied with respect to the other person; and

(E) if the applicant proposes to contract the operation
of the disposal facility to another person, the full name, address, and
telephone number of the management contractor, the full name and address of
each applicable principal, partner, or director of the contractor, the state
where it is organized, and the principal location where it does business;

(2) qualifications of the applicant:

(A) the applicable organizational structure of the
applicant, both off site and on site, including a description of lines of
authority and assignments of responsibilities, whether in the form of
administrative directives, contract provisions, or otherwise;

(B) the technical qualifications, including training,
experience, and professional licensure, registration or certification of the
applicant and members of the applicant's staff to engage in the proposed
activities, to include the minimum training, experience, and professional
licensure, registration or certification requirements for personnel filling key
positions described in Part (a)(2)(A) of this Rule;

(C) a description of the applicant's personnel training
program;

(D) the plan to maintain an adequate complement of
trained personnel on site to carry out waste receipt, handling, and disposal
operations in a safe manner;

(E) prior experience in the generation, processing,
use, transportation or disposal of radioactive material or in the treatment,
storage, transportation or disposal of hazardous waste including copies of all
notices of violations; assessments of any administrative, civil, criminal or
other penalties in connection therewith; and all information as to any finding
or determination that the applicant engaged in any of the above mentioned
activities without having in effect any license or permit required for such
activity;

(F) disclosure of any prior determination of civil or
criminal liability with respect to any other federal or state law or
regulation, including but not limited to any law or regulation governing the
transfer of securities, which may reflect on the applicant's character,
reputation or ability to comply with all requirements imposed on a licensee;
and

(G) upon request by the agency, a copy of any
application which the applicant may previously have submitted for any license
or permit required for any activity listed in Part (a)(2)(E) of this Rule;
information as to the disposition of such application including a copy of the
license or permit, information as to any restriction, suspension, revocation or
cancellation of any such license or permit; and any other information which may
be requested by the agency as to the applicant's experience and operating
practices with respect to the activities listed in Part (a)(2)(E) of this Rule;

(3) a description of:

(A) the location of the proposed disposal site;

(B) the general character of the proposed activities;

(C) the types and quantities of waste to be received,
possessed, and disposed of;

(D) plans for use of land disposal facility for purposes
other than disposal of wastes during operation, after closure or both;

(E) the proposed facilities and equipment;

(F) the proposed manifest and recording system;

(G) the treatment of any waste to be shipped off site;

(H) anticipated operating life of the facility; and

(I) the prelicensing and operational public
information program which addresses

(i) state and local government;

(ii) media and public;

(iii) acceptability within the community where the
facility is to be located; and

(iv) the program being implemented to ensure concerns
of the public are being met; and

(4) proposed time schedules for construction,
receipt of waste, and first emplacement of waste at the proposed land disposal
facility.

(b) The following are additional requirements applicable to
the information required in Parts (a)(2)(E) through (G) of this Rule:

(1) All information will be provided by the
applicant with respect to the applicant itself, any predecessor or parent
entity, any officer, director, partner or other principal of the applicant; any
stockholder or other entity holding five percent or more of the stock of, or
other interest in, the applicant; and any subsidiary or other entity in which
the applicant has an interest.

(2) All information will be provided for a
period of not less than 20 years or as may be determined by the agency, with
respect to a particular applicant or class of information, to be necessary to
discharge agency responsibility in G.S. 104E‑10.1(a).

(3) With the approval of the agency, the
applicant may submit any of the information, except as to the disposal of low‑level
radioactive waste, in summary form; provided that any summary must fairly and
accurately reflect the applicant's experience and operating practices and must
indicate the nature and extent of all violations of law and applicable rules.

(4) The agency may request that the applicant
provide any supplemental information needed to effect the purpose of Parts
(a)(2)(E) through (G) of this Rule. All such supplementary information
provided by or on behalf of the applicant will become a part of the
application.

(a) The specific technical information shall include the
following information needed for demonstration that the performance objectives
and the applicable technical requirements of this Section will be met:

(1) a description of the principal design
criteria and their relationship to the performance objectives, along with
identification of operating facilities of the same or similar design;

(2) a description of the design basis natural
events or phenomena and their relationship to the principal design criteria;

(3) a description of codes and standards which
the applicant has applied to the design and which will apply to construction of
the land disposal facility;

(4) a description of the design features of the
land disposal facility, the disposal units and engineered barriers, to include
those design features related to:

(A) infiltration of water;

(B) leachate collection and removal;

(C) integrity of covers for disposal units and
structural stability of backfill, engineered barriers, and covers;

(D) contact of wastes with standing water and
groundwater;

(E) disposal site drainage;

(F) disposal site closure and stabilization;

(G) elimination to the extent practicable of long‑term
disposal site maintenance, inadvertent intrusion, occupational exposures, and
disposal site monitoring;

(H) adequacy of the size of the buffer zone for
monitoring and potential mitigative measures; and

(I) retrieval;

(5) a description of the construction and
operation of the land disposal facility, to include, as a minimum:

(A) the methods of construction of disposal units and
engineered barriers;

(J) facilities for and methods of handling waste
including improperly packaged shipments;

(K) methods to control surface water and groundwater
access to the wastes;

(L) methods to be employed in the handling and disposal
of wastes containing chelating agents or other nonradiological substances that
might affect the meeting of the performance objectives of this Section; and

(M) a flow diagram of waste handling and disposal
operations, a description and accurate drawings of handling equipment, and any
special handling techniques to be employed;

(6) a description of the types, chemical and
physical forms, quantities, classification, and specifications of the
radioactive material proposed to be received, possessed, handled, and disposed
of at the land disposal facility, which shall include:

(A) estimated volume and activity of each waste class to
be received annually at the facility, and

(B) method for control of the rate at which waste is received;

(7) a description of the quality control
program, including audits and managerial controls, for the determination of
natural disposal site characteristics and for quality control during the
design, construction, operation, and closure of the land disposal facility and
during the receipt, handling, and emplacement of waste;

(8) a description of the radiation safety
program for control and monitoring of radioactive effluents to ensure
compliance with the performance objective in Rule .1223 of this Section and
occupational radiation exposure to ensure compliance with the requirements of
Section .1600 of this Chapter and to control contamination of personnel,
vehicles, equipment, buildings, and the disposal site; which description shall
address

(A) both routine operations and accidents; and

(B) procedures, instrumentation, facilities, and
equipment;

(9) an emergency response plan which addresses:

(A) on‑site response;

(B) public alert and notification;

(C) roles of local, county, state and regional agencies;

(D) training and public information; and

(E) if available, copies of most current emergency
response plans submitted to the U.S. Nuclear Regulatory Commission or an
agreement state;

(10) a manual of operating procedures and
emergency procedures including, but not limited to, those for fires, spills or
other events which result in contamination;

(11) a description of the administrative
procedures that the applicant will apply to control activities at the land
disposal facility including hours of proposed operation;

(12) a description of the radiation protection
program including provisions for keeping radiation doses to workers and to
members of the public as low as reasonably achievable (ALARA) and within
applicable limits specified in the rules of this Chapter;

(13) a description of the natural and demographic
disposal site characteristics as determined by disposal site selection and
characterization activities where the description must include geologic,
geotechnical, hydrologic, meteorologic, climatologic, air quality, natural
radiation background and biotic features of the disposal site and vicinity;
where the site characterization shall include sufficient and suitable data for
design and performance analysis; and where the minimum requirements include,
but are not limited to, the following:

(B) provisions for early identification of conditions
requiring remedial action, such as:

(i) detection of water in any disposal unit;

(ii) detection of radioactive contamination in
groundwater with sufficient sampling locations and frequencies to permit
identification of the disposal unit(s) causing the contamination;

(iii) establishment of specific sampling locations,
sampling frequencies and sample types as part of the licensee's environmental
monitoring program;

(iv) methods and frequencies for detection of water
or leachate in disposal units or trenches;

(v) any methods and associated frequencies for
inspecting, testing, maintaining or otherwise assessing the condition and
performance of disposal units, trenches and covers;

(vi) method and frequency for monitoring condition
and physical stability of the site;

(vii) any special monitoring, inspection or testing
which the licensee will institute in response to specific natural or man‑made
occurrences which may affect the ability of the facility to meet the
performance objectives of this Section; and

(viii) any periodic or ongoing evaluation of site
characteristics or changes in site characteristics which relate to the ability
of the facility to meet the performance objectives of this Section;

(C) a description of the corrective measures that will
be taken to correct the condition and otherwise assure compliance with the
performance objectives and technical requirements of this Section, such as:

(D) identification of facility features which facilitate
remedial actions, such as:

(i) design of disposal units and engineered
barriers which allows access for remedial action; and

(ii) other features necessary to implement the
action plan.

(b) Prior to implementation of detailed site investigations,
the applicant or the North Carolina Low‑Level Radioactive Waste
Management Authority shall develop a site characterization plan and submit it
for approval by the agency to ensure that:

(1) all available data on the site is obtained;

(2) unnecessary laboratory and field
investigations are not done;

(3) required or desired data is obtained;

(4) a proper sequencing and timely acquisition
of the required or desired data is planned and executed;

(5) site survey data stations will be designed
and located, insofar as feasible, so as to serve as planned permanent
monitoring stations as necessary; and

(6) technical and administrative coordination
of laboratory and field efforts is planned and executed.

(c) As site characterization proceeds, the applicant or the
North Carolina Low‑Level Radioactive Waste Management Authority and the
agency shall together review the site characterization results and the site
characterization plan at least once every 90 days to ensure that the plan is
still valid. The site characterization plan shall be modified as required by
the agency.

(d) Time‑variant site characteristics that require
site‑specific measurements shall be measured at such frequency and
duration so as to adequately define the seasonal range of the values. The
minimum period of measurement shall be one year and shall be supplemented,
where possible, with regional data covering a longer time period.

A license application for land disposal of waste shall
include site‑specific environmental information (or reconnaissance level
information when appropriate) which addresses and quantifies to the extent practicable,
but is not limited to, the following:

(1) statement of need and a description of the proposed
activities identifying the location of the proposed site, the character of the
proposed activities, and any plans for use of the facility for purposes other
than handling and disposal of waste;

(2) area and site characteristics including:

(a) historical and cultural landmarks, state and
national parks, wilderness and wilderness study areas, archaeology, and
demography;

(b) all buildings to a three mile radius;

(c) existing and projected populations and land
use in the general area to a ten mile radius;

(d) nearby drinking water supply watersheds,
groundwater recharge areas, flood plains, wetland areas and other natural
resources such as endangered species habitats, proximity to parks, forests,
wilderness areas and historical sites, and air quality; and

(3) any irreversible or irretrievable commitments of
natural resources which would be involved should the area be developed as a
disposal site;

(4) to the extent performed by the applicant, site
selection process, including considerations of alternative sites and the
interrelationships between location of waste generators, transportation costs
and means, site characteristics, and compatibility with current land uses;

(5) to the extent performed or selected by the
applicant, project alternatives, including a discussion of the alternatives
considered by the applicant for handling and disposal of waste;

(6) radiological and nonradiological impacts of the
proposed action, including:

(a) surface and groundwater impacts;

(b) socioeconomic impacts;

(c) short‑ and long‑term impacts on
public health and safety;

(d) impacts resulting from irreversible or
irretrievable commitments of resources; and

(e) aesthetic factors such as the visibility,
appearance and noise level of the facility;

(b) all credible accidents and projected off‑site
impacts, including those occurring in transportation of the waste to or from
the facility; and

(c) mitigation of accidents and protection of
the public;

(8) a list of all governmental permits, licenses,
approvals, and other entitlements obtained or which must be obtained in
connection with the proposed action along with the current status of
applications for and issuance of such permits, licenses, approvals, and other
entitlements;

(9) a description of the maximum projected quantity and
concentration of each radionuclide and toxic or hazardous constituent of the
waste released annually to the air, to the water and to the soil;

(10) a description of the maximum projected radiation
doses to off‑site populations; and

(11) a description of the maximum projected off‑site
radionuclide concentrations in air, soil, water and food.

The specific technical and environmental information shall
also include the following analyses needed to demonstrate that the performance
objectives of this Section will be met:

(1) pathways analyzed in demonstrating protection of
the general population from releases of radioactivity shall include air, soil,
groundwater, surface water, plant uptake, and exhumation by burrowing animals.
The analyses shall:

(a) clearly identify and differentiate between
the roles performed by the natural disposal site characteristics and design
features in isolating and segregating the wastes; and

(b) clearly demonstrate that there is reasonable
assurance that the potential exposures to humans from the release of radioactivity
will not exceed the limits set forth in Rule .1223 of this Section.

(2) Analyses of the protection of individuals from
inadvertent intrusion shall include demonstration that there is reasonable
assurance that the waste classification and segregation requirements will be
met and that adequate barriers to inadvertent intrusion will be provided.

(3) Analyses of the protection of individuals during
operations shall include assessments of expected exposures due to routine
operations and likely accidents during handling, storage, and disposal of
waste. The analyses shall provide reasonable assurance that exposures will be
controlled to meet the requirements of Section .1600 of this Chapter.

(4) Analyses of the long‑term stability of the
disposal site and the need for ongoing active maintenance after closure shall
be based upon analyses of active natural processes such as erosion, mass
wasting, slope failure, settlement of wastes and backfill, infiltration through
covers over disposal units and adjacent soils, and surface drainage of the
disposal site. The analyses shall provide reasonable assurance that there will
not be a need for ongoing active maintenance of the disposal site following
closure.

(1) a certification by the custodial agency or federal
government which owns the disposal site that the custodial agency or federal
government is prepared to accept transfer of the license when the provisions of
Rule .1220 of this Section are met, and will assume responsibility for
custodial care after site closure and postclosure observation and maintenance;

(2) evidence that arrangements have been made for
assumption of ownership in fee by the state or federal government before the
agency issues a license where the proposed disposal site is on land not owned
by the state or federal government;

(3) a description of the ownership of the land and
fixtures that are part of the proposed disposal site; which description must
include a plat plan describing the site and identifying the ownership of the
surface and subsurface estates included, and, where portions of the site have
been leased or will be leased to others, the terms of the lease agreement; and

(4) a description of the contractual terms and
conditions of any agreement for the management or operation of the proposed
disposal site.

(a) The financial information shall be sufficient to
demonstrate that the financial qualifications of the applicant are adequate to
carry out the activities for which the license is sought and meet other
financial assurance requirements of this Section. In addition to information
required in Rule .1205 of this Section, the applicant shall provide the
following financial information:

(1) financial organization of the company;

(2) a list of all subsidiary companies and
their locations;

(3) audited financial statements for the most
recent calendar or fiscal year;

(4) interim statements, if it has been six
months or more since the end of the reporting year;

(E) whether the company is licensed by the North
Carolina Insurance Commissioner;

(6) status and nature of any outstanding civil
action to which the applicant is a party, and of any administrative or criminal
proceeding against the applicant; and the same information with respect to any
corporation, partnership, firm, company or association which holds an interest
of five percent or more in the applicant, or in which the applicant holds any
interest; subject to the following provisions:

(A) upon request by the agency, the information required
by this Subparagraph shall include a copy of any document which is a part of
public record in any such action or proceeding;

(B) with the approval of the agency, the applicant may
submit any of the information required by this Subparagraph in summary form,
provided that any summary must fairly and accurately reflect the scope and
content of such information;

(C) with the approval of the agency, the applicant may
exclude information which would otherwise be required by this Subparagraph
provided that the applicant identifies the types of information to be omitted
and satisfies the agency that such types of information are not material to the
applicant's ability to operate a facility under this Section; and

(D) unless specifically requested by the agency, the
following types of actions if brought in North Carolina, or equivalent types of
actions if brought in any other jurisdiction, are excluded from the reporting
requirements of this Subparagraph:

(i) small claims actions as defined in G.S. 7A‑210,

(ii) infractions as defined in G.S. 14‑3.1,
and

(iii) misdemeanors under Chapter 20 (Motor Vehicles)
of the General Statutes; and

(7) details of any other resources such as
reserves or bonds to cover potential damages.

(c) The information required in Paragraphs (a) and (b) of
this Rule shall be updated annually to the extent that such information is not
provided in the annual certified financial statement required in Rule .1238 of
this Section.

(a) An application for a license under this Section, and
any amendments thereto, shall be filed with the agency, and shall be signed
under oath by the applicant or the applicant's authorized representative who
shall furnish documentation conferring authority. The application filed with
the agency shall consist of one signed original and 12 true copies.

(b) Additional copies of the application shall be retained
by the applicant for distribution in accordance with written instructions from
the agency.

In its application, the applicant may incorporate, by
reference, information contained in previous applications, statements, or
reports filed with the agency if these references are clear and specific.

(a) The application shall be as complete as possible in the
light of information that is available at the time of submittal.

(b) It shall be the responsibility of the applicant to
supplement its application in a timely manner in order to reflect any material
changes in the information required as a part of the application or available
to the applicant, so as to permit the agency to review any such information
prior to issuance of a license.

A license for the receipt, possession, and disposal of waste
containing or contaminated with radioactive material shall be issued by the
agency upon finding that the issuance of the license and operation of the
facility will not constitute an unreasonable risk to the health and safety of
the public or have a long‑term detrimental impact on the environment, and
that:

(1) The applicant is qualified by reason of training
and experience to carry out the disposal operations requested in a manner that
adequately protects public health and minimizes danger to life, property or the
environment;

(2) The applicant's proposed disposal site, disposal
design, land disposal facility operations (including equipment, facilities, and
procedures), disposal site closure, and postclosure institutional care are
adequate to protect the public health and safety in that they provide
reasonable assurance that the general population will be protected from
releases of radioactivity as specified in this Section;

(3) The applicant's proposed disposal site, disposal
site design, land disposal facility operations (including equipment,
facilities, and procedures), disposal site closure, and postclosure
institutional control are adequate to protect the public health and safety in
that they will provide reasonable assurance that individual inadvertent
intruders are protected in accordance with this Section;

(4) The applicant's proposed land disposal facility
operations (including equipment, facilities, and procedures) are adequate to
protect the public health and safety in that they will provide assurance that
the standards for radiation protection set out in Section .1600 of this Chapter
will be met;

(5) The applicant's proposed disposal site, disposal
site design, land disposal facility operations, disposal site closure, and
postclosure institutional control are adequate to protect the public health and
safety and the environment in that they will provide reasonable assurance that long‑term
stability of the disposed waste and the disposal site will be achieved and will
eliminate to the extent practicable the need for ongoing active maintenance of
the disposal site following closure;

(6) The applicant has provided reasonable assurance that
the applicable technical requirements of this Section will be met;

(7) The applicant's proposal for institutional control
provides reasonable assurance that such control will be provided for the length
of time found necessary to ensure the findings in Items (2) through (5) of this
Rule and that the institutional control meets the requirements in this Section;

(8) The information on financial assurances meets the
requirements of this Section;

(9) Any additional information as requested by the
agency pursuant to Rule .0317 of this Chapter is adequate; and

(10) The requirements of this Section have been met; and

(11) The applicant proposes a facility to be operated
pursuant to G.S. 104G.

(a) A license issued under this Section, or any right
thereunder, may not be transferred, assigned, or in any manner disposed of,
either voluntarily or involuntarily, directly or indirectly, through transfer
of control of the license to any person, unless the agency finds, after
securing full information, that the transfer is in accordance with the
provisions of the North Carolina Radiation Protection Act (Act) and gives its
consent in writing in the form of a license amendment.

(b) At any time before termination of the license, the
licensee shall submit written statements under oath upon request of the agency
to enable the agency to determine whether or not the license should be
modified, suspended, or revoked.

(c) The license shall be transferred to the custodial
agency only on the full implementation of the final closure plan as approved by
the agency, including postclosure observation and maintenance.

(d) The licensee shall be subject to the provisions of the
Act now or hereafter in effect, and to all rules and orders of the agency.

(e) Any license may be revoked, suspended or modified in
whole or in part for any material false statement in the application or any
misstatement of fact required under the Act, or because of conditions revealed
by any application or statement of fact or any report, record, or inspection or
other means which would warrant the agency to refuse to grant a license on the
original application, or for failure to operate the facility in accordance with
the terms of the license, or for any violation of, or failure to observe any of
the terms and conditions of the Act, or any rule, license or order of the
agency.

(f) Each person licensed by the agency pursuant to the
rules in this Section shall confine possession and use of radioactive materials
to the locations and purposes authorized in the license.

(g) No waste may be disposed of until the agency has
inspected the land disposal facility and has found it to be in conformance with
the description, design, and construction described in the application for a
license.

(h) The agency may, in accordance with 46 FR 7540,
incorporate in any license at the time of issuance, or thereafter, by
appropriate order, additional requirements and conditions with respect to the
licensee's receipt, possession, and disposal of waste as it deems appropriate
or necessary in order to:

(1) protect the health and safety of the public
and the environment, or minimize danger to life or property; and

(2) require reports and the keeping of records,
and to provide for inspections of activities under the license that may be
necessary or appropriate to effectuate the purposes of the Act and rules
thereunder.

(i) The agency may incorporate in any license at
the time of issuance, or thereafter, by appropriate order, a requirement that
the licensee provide the agency with continuing information with respect to any
information required as a part of the license application.

(j) Except as provided otherwise by the agency pursuant to
Paragraph (h) of this Rule and consistent with G.S. 104E‑25(h), the
licensee shall not accept or dispose of:

(1) liquid waste which has not been solidified
in a manner deemed acceptable by the agency as meeting the requirements in G.S.
104E‑25(h);

(2) any waste containing chelating agents in
concentrations greater than one‑tenth of one percent by weight unless:

(A) the chelating agent content does not exceed eight
percent by weight, and

(B) the waste has been solidified and meets the
stability requirements for class B and C waste as may be specified by the
agency after consideration of current regulatory guides on waste form of the
U.S. Nuclear Regulatory Commission, provided however that high integrity
containers alone are not acceptable to achieve this stability requirement; and

(3) such other waste as the agency may prohibit
as necessary to ensure that the performance objectives of this Section will be
met.

(k) Each license will be issued for a period of five years
from the date of issuance. The authority to dispose of wastes expires on the
date stated in the license except as provided in Rule .1217 of this Section.

(a) Any expiration date on a license applies only to the
above ground activities and to the authority to dispose of waste. Failure to
renew the license shall not relieve the licensee of responsibility for
implementing site closure, postclosure observation, and transfer of the license
to the custodial agency. An application for renewal or an application for
closure under Rule .1218 of this Section shall be filed at least 90 days prior
to license expiration.

(b) Applications for renewal of a license shall be filed in
accordance with Rules .1204 through .1213 of this Section. Applications for
closure shall be filed in accordance with Rules .1211, .1212, .1213 and .1218
of this Section.

(c) In any case in which a licensee has timely filed an
application for renewal of a license, the license for continued receipt and
disposal of licensed materials shall not expire until the agency has taken
final action on the application for renewal.

(d) In determining whether a license will be renewed, the
agency will apply the criteria set forth in Rule .1214 of this Section.

(e) Upon approval of an application for renewal pursuant to
provisions of this Rule, the agency will issue the license renewal amendment to
expire five years from the date of final agency action on the application for
renewal.

(a) Prior to final closure of the disposal site, or as
otherwise directed by the agency, the applicant shall submit an application to
amend the license for closure. This closure application shall include a final
revision and specific details of the disposal site closure plan included as
part of the license application submitted under Rule .1206 of this Section that
includes each of the following:

(1) any additional geologic, geochemical,
hydrologic, or other data obtained during the operational period pertinent to
the long‑term containment of emplaced wastes;

(2) the results of tests, experiments, or any
other analyses relating to backfill of excavated areas, closure and sealing,
waste migration and interaction with emplacement media, or any other tests,
experiments, or analyses pertinent to the long‑term containment of
emplaced waste within the disposal site;

(3) any proposed revision of plans for:

(A) decontamination and dismantlement of surface facilities;

(B) backfilling of excavated areas; or

(C) stabilization of the disposal site for postclosure
care; and

(4) any significant new information regarding
the environmental impact of closure activities and long‑term performance
of the disposal site.

(b) Upon review and consideration of an application to
amend the license for closure submitted in accordance with Paragraph (a) of
this Rule, the agency may issue an amendment authorizing closure if there is
reasonable assurance that the long‑term performance objectives of this
Section will be met.

Following completion of closure authorized in Rule .1218 of
this Section, the licensee shall observe, monitor, and carry out necessary
maintenance and repairs at the disposal site until the site closure is complete
and the license is transferred by the agency in accordance with Rule .1220 of
this Section. Responsibility for the disposal site shall be maintained by the
licensee for five years. A shorter or longer time period for postclosure observation
and maintenance may be established and approved as part of the site closure
plan, based on site‑specific conditions.

Following closure and the period of postclosure observation
and maintenance, the licensee may apply for an amendment to transfer the
license to the custodial agency. The license shall be transferred when the
agency finds:

(1) that the closure of the disposal site has been made
in conformance with the licensee's disposal site closure plan, as amended and
approved as part of the license;

(2) that reasonable assurance has been provided by the
licensee that the performance objectives of this Section are met;

(3) that any funds and necessary records for care will
be transferred to the Long‑Term Care Fund and the custodial agency,
respectively;

(4) that sufficient funds have accumulated in the Long‑Term
Care Fund to support anticipated agency and custodial agency costs for all
future observation, monitoring, maintenance and remedial actions;

(5) that the postclosure monitoring program is
operational for implementation by the custodial agency; and

(6) that the custodial agency or the federal agency
which will assume responsibility for institutional control of the disposal site
is prepared to assume responsibility and ensure that the institutional
requirements found necessary under Item (7) of Rule .1214 of this Section will be
met.

(a) Following any period of institutional control needed to
meet the requirements found necessary under Rule .1214 of this Section, the
custodial agency may apply for an amendment to terminate the license.

(b) This application shall be filed, and will be reviewed,
in accordance with the provisions of Rule .1211 of this Section and Paragraph
(a) of this Rule.

(c) A license will be terminated only when the agency
finds:

(1) that the institutional control requirements
found necessary under Item (7) of Rule .1214 of this Section have been met; and

(2) that any additional requirements resulting
from new information developed during the institutional control period have
been met, and that permanent monuments or markers warning against intrusion
have been installed.

Land disposal facilities shall be sited, designed, operated,
closed, and controlled after closure so that reasonable assurance exists that
exposures to humans do not exceed the limits established in the performance
objectives in Rules .1223 through .1225 of this Section.

10A NCAC 15 .1223 PROTECTION OF POPULATION FROM RELEASES
OF RADIOACTIVITY

(a) The design goal of the engineered barrier and other
requirements in this Section is confinement of the disposed waste and contained
radioactivity for at least the designed life of the required engineered
barriers, with reasonable assurance that any release of radioactivity or
radiation will not exceed the limits stated in Paragraph (b) of this Rule and
will be as low as reasonably achievable as provided in Paragraph (c) of this Rule.

(b) Land disposal facilities shall not cause external
radiation levels or release concentrations of radioactive material to the
general environment in groundwater, surface water, air, soil, plants, or
animals that result in an annual equivalent dose to any member of the public,
above background as determined in accordance with Rule .1231 of this Section,
exceeding:

(1) 25 millirems to the whole body,

(2) 75 millirems to the thyroid, or

(3) 25 millirems to any other organ.

(c) In accordance with the ALARA plan required by Rule
.1206 of this Section, the licensee shall maintain releases of radioactivity in
effluents to the general environment and resultant radiation dose to the public
as low as reasonably achievable below the limits imposed in Paragraph (b) of
this Rule.

Design, operation, and closure of the land disposal facility
shall ensure protection of any individual inadvertently intruding into the
disposal site and occupying the site or contacting the waste at any time after
active institutional controls over the disposal site are removed.

(a) Operations at the land disposal facility shall be
conducted in compliance with the standards for radiation protection set out in
Section .1600 of this Chapter, except as provided in Rule .1223 of this Section
for the off‑site public.

(b) In accordance with the ALARA plan required by Rule
.1206 of this Section, the licensee shall maintain occupational radiation doses
as low as reasonably achievable below the occupational radiation dose limits
established in Section .1600 of this Chapter.

The disposal facility shall be sited, designed, used,
operated, and closed to achieve long‑term stability of the disposal site
and to eliminate to the extent practicable the need for ongoing active
maintenance of the disposal site following closure so that only surveillance,
monitoring, and minor custodial care are required.

(a) The disposal site shall be capable of being
characterized, modeled, analyzed, and monitored.

(b) Within the region where the facility is to be located,
a disposal site should be selected so that projected population growth and
future developments are not likely to affect the ability of the disposal
facility to meet the performance objectives of this Section.

(c) Areas shall be avoided having known natural resources
which, if exploited, would result in failure to meet the performance objectives
of this Section.

(d) The disposal site shall be well drained and free of
areas of flooding or frequent ponding. Waste disposal shall not take place in
a 100‑year flood plain, coastal high‑hazard area or wetland, as
defined in Executive Order 11988, "Floodplain Management Guidelines."

(e) Upstream drainage areas shall be minimized to decrease
the amount of runoff which could erode or inundate disposal units.

(f) The disposal site shall provide sufficient depth to the
water table that groundwater intrusion, perennial or otherwise, into the waste
will not occur, provided however that the depth to the water table shall be
sufficient to ensure that the bottom of the disposal facility may be at least
seven feet above the seasonal high water table as provided in G.S. 104E‑25(j).

(g) Areas shall be avoided that are the recharge areas of
sole source aquifers or drinking water supply watersheds unless it can be
demonstrated with reasonable assurance that the disposal site will be designed,
constructed, operated, and closed without an unreasonable risk to an aquifer or
drinking water supplies.

(h) Waste disposal shall not take place within 1000 feet of
drinking water wells, except for on‑site wells controlled by the licensee
and used to supply water solely to the facility. This minimum distance may be
increased in any lateral direction when required by site‑specific
conditions.

(i) The hydrogeologic unit used for disposal shall not
discharge groundwater to the surface within the disposal site.

(j) Areas shall be avoided where tectonic processes such as
faulting, folding, seismic activity, or vulcanism may occur with such frequency
and extent to significantly affect the ability of the disposal site to meet the
performance objectives of this Section, or may preclude defensible modeling and
prediction of long‑term impacts.

(k) Areas shall be avoided where surface geologic processes
such as mass wasting, erosion, slumping, landsliding, or weathering occur with
such frequency and extent to significantly affect the ability of the disposal
site to meet the performance objectives of this Section, or may preclude
defensible modeling of long‑term impacts.

(l) The disposal site shall not be located where nearby
facilities or activities could adversely impact the ability of the site to meet
the performance objectives of this Section or significantly mask the
environmental monitoring program.

(b) Site design features shall be directed toward long‑term
isolation and avoidance of the need for continuing active maintenance after
site closure.

(c) The disposal site design and operation shall be
compatible with the disposal site closure and stabilization plan and lead to
disposal site closure that provides reasonable assurance that the performance
objectives of this Section will be met.

(d) The disposal site shall be designed to complement and
improve, where appropriate, the ability of the disposal site's natural
characteristics to assure that the performance objectives of this Section will
be met.

(e) Covers shall be designed to minimize water
infiltration, to direct percolating or surface water away from the disposed
waste, and to resist degradation by surface geologic processes and biotic
activity.

(f) Surface features shall direct surface water drainage
away from disposal units at velocities and gradients which will not result in
erosion that will require ongoing active maintenance.

(g) The disposal site shall be designed to minimize the
contact of water with waste during storage, the contact of standing water with
waste during disposal, and the contact of percolating or standing water with
wastes after disposal.

(h) The disposal units shall incorporate engineered
barriers. The disposal units and incorporated engineered barriers shall be
designed and constructed to meet the performance objectives, technical
requirements and design criteria in G.S. 104E‑25 and the following
additional requirements:

(1) The engineered barriers shall provide
reasonable assurance that they will complement, and where appropriate improve,
the land disposal facility's ability to isolate the radioactive waste through
the institutional control period;

(3) Engineered barriers shall prevent contact
between the surrounding earth and the waste, except for earth that may be used
as fill material within the disposal unit; and

(4) The disposal units shall be constructed or
emplaced in a manner which will ensure that the bottom of the disposal facility
is at least seven feet above the seasonal high water table or more if necessary
to meet the performance objectives of this Section.

(i) The licensee shall develop, operate and maintain the
site in a manner that will not diminish the hydrogeological performance of the
site below the requirements contained in the rules of this Section.

(a) Wastes designated as Class A pursuant to Rule .1650 of
this Chapter shall be segregated from other wastes by placement in disposal
units which are sufficiently separated from disposal units for the other waste
classes so that any interaction between Class A wastes and other wastes will
not result in the failure to meet the performance objectives of this Section.
This segregation is not necessary for Class A wastes if they meet the stability
requirements in Rule .1651(b) of this Chapter.

(b) Wastes designated as Class C pursuant to Rule .1650 of
this Chapter shall be disposed of so that the top of the waste is a minimum of
five meters below the top surface of the cover or shall be disposed of with
intruder barriers that are designed to protect against an inadvertent intrusion
for at least 500 years.

(c) Wastes shall be emplaced in a manner that maintains the
package integrity during emplacement, minimizes the void spaces between packages,
and permits the void spaces to be filled.

(d) Void spaces between waste packages shall be filled with
earth or other material to reduce future subsidence within the fill.

(e) Waste shall be placed and covered in a manner that
limits the radiation dose rate at the surface of the cover to levels that at a
minimum will permit the licensee to comply with all provisions of Rule .1611 of
this Chapter at the time the license is transferred pursuant to Rule .1220 of
this Section.

(f) The boundaries and locations of each disposal unit
shall be accurately located and mapped by means of land survey. Disposal units
shall be marked in such a way that the boundaries of each unit can be easily
defined. Three permanent survey marker control points, referenced to the North
American Datum of 1983 (NAD83) and the current North American Vertical Datum
(NAVD), as defined and maintained by the National Geodetic Survey, shall be
established on the site to facilitate surveys. The three established control
stations shall be positioned both horizontally and vertically by surveys tied
to the NAD83 and NAVD as maintained in the North Carolina Geodetic Survey
record files. All such surveys shall comply with standards and specifications
in "Standards and Specifications for Geodetic Control Networks (September
1984)" and "Geometric Geodetic Survey Accuracy Standards and
Specifications for Geodetic Surveys using GPS Relative Positioning
Techniques" of the Federal Geodetic Control Committee, as approved by
North Carolina Geodetic Survey.

(g) A buffer zone of land shall be maintained between any
buried waste and the disposal site boundary and beneath the disposed waste.
The buffer zone shall be of adequate dimensions to carry out environmental
monitoring activities specified in Rule .1231(c) of this Section and to permit
mitigative measures if needed.

(h) Closure and stabilization measures as set forth in the
approved site closure plan shall be carried out as each disposal unit is filled
and covered.

(j) Mixed waste is prohibited. The Radiation Protection
Commission may waive the prohibition of disposal of mixed waste provided the
Radiation Protection Commission determines that the following conditions are
met:

(a) A preoperational monitoring program shall be conducted
to provide basic environmental data on the disposal site characteristics and to
determine the pre‑existing background radiation levels. At the time a license
application is submitted, a preoperational monitoring program shall have been
conducted to provide basic environmental data on the disposal site
characteristics. The data shall include information about the ecology,
meteorology, climate, hydrology, geology, geochemistry, and seismology of the
disposal site. For those characteristics that are subject to seasonal
variation, data must cover at least a 12 month period.

(b) During the land disposal facility site construction and
operation, the licensee shall maintain a monitoring program where:

(1) Measurements and observations shall be made
and recorded to provide data to evaluate the potential health and environmental
impacts during both the construction and the operation of the facility, and to
enable the evaluation of long‑term effects and the need for mitigative
measures; and

(2) The monitoring program shall be capable of
providing early warning of releases of radionuclides before they reach the
disposal site boundary.

(c) After the disposal site is closed, the licensee
responsible for postoperational surveillance of the disposal site shall
maintain a monitoring program where:

(1) The monitoring program is based on the
operating history and the closure and stabilization of the disposal site; and

(2) The monitoring program shall be capable of
providing early warning of releases of radionuclides before they reach the
disposal site boundary, and shall include sufficient numbers, types and
locations of wells to permit detection of groundwater radioactive
contamination.

(a) Disposal of waste received from other persons may be
permitted only on land owned in fee simple by the State of North Carolina or
the federal government at a facility which is sited and operated pursuant to
provisions of G.S. 104G.

(b) The custodial agency shall conduct an institutional
control program to physically control access to the disposal site following
transfer of control of the disposal site from the disposal site operator.

(c) The institutional control program shall also include,
but not be limited to, conducting an environmental monitoring program at the
disposal site, periodic surveillance, minor custodial care, and other
requirements as determined by the agency; and administration of funds to cover
the costs for these activities.

(d) The period of institutional controls will be determined
by the agency, but shall be no less than 100 years following transfer of
control of the disposal site to the custodial agency.

(e) Notwithstanding the period of institutional control
which may be required by the agency pursuant to Paragraph (d) of this Rule,
such institutional control may not be relied upon for the purpose of meeting
site performance criteria for more than 100 years following transfer of control
of the disposal site to the custodial agency.

The applicant shall show that it either possesses the
necessary funds or has reasonable assurance of obtaining the necessary funds,
or by a combination of the two, to cover the estimated costs of conducting all
licensed activities over the planned operating life of the project.

(a) The applicant shall provide assurances prior to the
commencement of operations that sufficient funds will be available to carry out
disposal site closure, stabilization and institutional controls, including:

(1) decontamination or dismantlement of land
disposal facility structures; and

(2) closure and stabilization of the disposal
site so that following transfer of the disposal site to the custodial agency,
the need for ongoing active maintenance is eliminated to the extent practicable
and only minor custodial care, surveillance, and monitoring are required.

(b) The amount of the assurances in Paragraph (a) of this
Rule shall be established by the Commission and shall be based on agency‑approved
cost estimates reflecting the agency‑approved plan for disposal site
closure and stabilization and agency estimates of the costs which may be
associated with the period of institutional controls. In estimating such
costs, the agency shall consider applicant‑prepared cost estimates which
shall take into account total costs that would be incurred if an independent
contractor were hired to perform the closure and stabilization work.

(c) The licensee shall submit the financial or surety arrangements
annually for review by the agency to assure that sufficient funds will be
available for completion of the closure plan and for anticipated institutional
care.

(d) The amount of the licensee's financial or surety
arrangement shall change in accordance with changes in the predicted costs of
closure, stabilization and institutional care. Factors affecting closure,
stabilization and institutional care cost estimates include inflation,
increases in the amount of disturbed land, changes in engineering plans,
closure and stabilization that has already been accomplished, and any other
conditions affecting costs. The financial or surety arrangements shall be
sufficient at all times to cover the costs of closure, stabilization and
institutional care of the disposal units that are expected to be used before
the next license renewal.

(e) The amount of the licensee's financial and surety
arrangements as determined in Paragraph (d) of this Rule may be reduced
annually by the actual amount of funds deposited by the licensee in the Long‑Term
Care Fund pursuant to such fees as may be established by the North Carolina Low‑Level
Radioactive Waste Management Authority under the provisions of G.S. 104G‑15.

(f) The financial or surety arrangement shall be written for
a specified period of time, shall run in favor of the Long‑Term Care
Fund, and shall be automatically renewed unless the person who issues the
surety notifies the agency, the site owner, and the principal (the licensee)
not less than 90 days prior to the renewal date of its intention not to renew.
In such a situation, the licensee must submit a replacement surety within 30
days after notification of cancellation. If the licensee fails to provide a
replacement surety acceptable to the agency within 30 days after notification
of cancellation, the agency may require the North Carolina Low‑Level
Radioactive Waste Management Authority to collect on the original surety for
deposit in the Long‑Term Care Fund.

(g) Proof of forfeiture shall not be necessary to collect
the surety so that, in the event that the licensee does not provide an
acceptable replacement surety within the required time, the surety shall be
automatically collected prior to its expiration. The conditions described in
this Paragraph and in Paragraph (f) of this Rule shall be clearly stated on any
surety instrument.

(h) Financial or surety arrangements generally acceptable
to the Commission and agency include: surety bonds, cash deposits,
certificates of deposit, deposits of government securities, escrow accounts,
irrevocable letters or lines of credit, trust funds, and combinations of the
above or such other types of arrangements as may be approved by the agency,
consistent with provisions of G.S. 104E‑18. Self‑insurance, or any
arrangement which essentially constitutes self‑insurance, will not
satisfy the surety requirement for private sector applicants.

(i) The licensee's financial or surety arrangement shall
remain in effect until the closure and stabilization program has been completed
and approved by the agency, custody of the site and disposed waste has been
accepted by the custodial agency, and the license has been terminated by the
agency.

(j) In order to avoid unnecessary duplication of expense,
the agency will accept sureties that have been consolidated with earmarked
financial or surety arrangements established to meet requirements of federal or
other state agencies for such decontamination, closure, and stabilization. The
agency will accept these arrangements only if they are considered adequate to
satisfy the requirements of Paragraphs (a) to (i) of this Rule and that portion
of the surety which covers the closure of the disposal site is clearly
identified and committed for use in accomplishing these activities.

(a) Each licensee shall maintain any records and make any
reports in connection with the licensed activities, as may be required by the
conditions of the license or by the rules.

(b) Records which are required by the rules or by license
conditions shall be maintained for a period specified by the appropriate rules
or by license conditions. If a retention period is not otherwise specified,
these records shall be maintained and transferred to the agency as specified in
the rules in Section .1600 of this Chapter as a condition of license
termination unless the agency otherwise authorizes their disposition.

(c) Records which shall be maintained pursuant to this
Section may be the original or a copy or microfilm, provided the records are
capable of being clearly and legibly reproduced. The following records shall
be maintained in a permanent form specified by or approved by the agency in
writing:

(1) the location and inventory of disposed waste,
to include generator‑specific and other information which may be required
by the agency;

(4) any other records that the agency deems
appropriate to be maintained in a permanent form based on a determination that
retention of the records is necessary to ensure protection of the public and
environment during the institutional control period.

(d) If there is a conflict between the agency's rules or
license conditions pertaining to the retention period for the same type of
record, the longer retention period specified takes precedence.

(e) Notwithstanding Paragraphs (a) through (d) of this
Rule, copies of records of the location and the quantity of wastes contained in
the disposal site shall be transferred to the agency upon transfer of the
license to the custodial agency or upon termination of the license.

(f) Following receipt and acceptance of a shipment of
waste, the licensee shall record the date of receipt and disposal of the waste,
the location in the disposal site, the condition of the waste packages as
received, any discrepancies between materials listed on the manifest and those
received, and any evidence of leaking or damaged packages or radiation or
contamination levels in excess of limits specified in U.S. Department of
Transportation and agency rules. The licensee shall briefly describe any
repackaging operations of any of the waste packages included in the shipment,
plus any other information required by the agency as a license condition.

(g) Each licensee authorized to dispose of waste received
from other persons shall file a copy of its financial report or a certified
financial statement annually with the agency in order to update the information
base for determining financial qualifications.

(h) Each licensee authorized to dispose of waste materials
received from other persons pursuant to this Section shall submit annual
reports to the agency in accordance with Subparagraphs (h)(1) through (h)(4) of
this Rule.

(1) Reports shall be submitted by the end of
the first calendar quarter of each year for the preceding year.

(2) If the quantities of radioactive materials
released during the reporting period, monitoring results, or maintenance
performed are significantly different from those expected in the materials
previously reviewed as part of the licensing action, the reports shall cover
this specifically.

(3) The reports shall include:

(A) specification of the quantity of each of the
principal radionuclides released to unrestricted areas in liquid and in
airborne effluents during the preceding year;

(a) The agency may require at any disposal site that the
licensee provide appropriate office and storage space for a resident inspector
who is employed by the agency.

(b) The agency may require the licensee to refuse acceptance
of low‑level radioactive waste from any generator, if the agency makes
one or more of the following determinations:

(1) the generator has shipped waste to the
licensee's facility without filing the manifest required in Rule .1633 of this
Chapter;

(2) the generator has improperly described
waste in a manifest contrary to the requirements in Rule .1633 of this Chapter;

(3) the generator has shipped to the licensee's
facility waste which is prohibited by any rule of this Chapter or by condition
of the site operator's license;

(4) the generator has shipped to the licensee's
facility improperly labeled or packaged containers of waste; or

(5) the generator has failed to comply with
applicable rules of this Chapter.

(c) In the event that the agency prohibits the licensee
from receiving waste from any generator pursuant to Paragraph (b) of this Rule,
the agency shall notify the licensee and the generator both verbally and in
writing, stating the nature and basis for the prohibition, the corrective actions
required to terminate the prohibition and the rights of the affected persons
regarding the prohibition.

(a) The licensee shall submit to the agency monthly reports
of all containers or shipments of waste which arrive at the site and are found
by licensee personnel to be in violation of any provision of the rules of this
Chapter. The monthly reports shall include the name, mailing address,
telephone number, radioactive material license number, and description and date
of the violation; shall cover a period of one calendar month; and shall be
submitted to the agency within 20 days after the end of the calendar month
covered by the report.

(b) The licensee shall immediately notify the agency in the
event that the licensee determines that the limits imposed in Paragraph (b) of
Rule .1223 of this Chapter have been exceeded.

(c) The licensee shall notify the agency within 30 days
after the licensee determines that on‑site migration in groundwater of
disposed radioactivity has occurred along with an explanation of the remedial
actions taken in accordance with applicable requirements in this Section.

(d) The licensee shall notify the agency within 24 hours
after the licensee determines that off‑site migration of disposed
radioactivity has occurred.

(e) The licensee shall also notify the agency in accordance
with applicable requirements in Section .1600 of this Chapter.

(1) "Energy compensation sources (ECS)" means
a sealed source, with an activity not exceeding 100 microcuries (3.7 MBq), used
within a logging tool or other tool components, to provide a reference standard
to maintain the tool's calibration when in use.

(2) "Field station" means a facility where
radioactive sources may be stored or used and from which equipment is
dispatched to temporary jobsites.

(6) "Mineral logging" means any logging
performed for the purpose of mineral exploration other than oil or gas.

(7) "Personal supervision" means guidance and
instruction by the supervisor who is physically present at the jobsite and
watching the performance of the operation in such proximity that contact can be
maintained and immediate assistance given as required.

(8) "Radioactive marker" means radioactive
material placed subsurface or on a structure intended for subsurface use for
the purpose of depth determination or direction orientation.

(9) "Source holder" means a housing or
assembly into which a radioactive source is placed for the purpose of
facilitating the handling and use of the source in well-logging operations.

(10) "Subsurface-tracer study" means the
release of a substance tagged with radioactive material for the purpose of
tracing the movement or position of the tagged substance in the well-bore or
adjacent formation.

(11) "Temporary jobsite" means a location to
which radioactive materials have been dispatched to perform wireline-service
operations or subsurface-tracer studies.

(12) "Tritium neutron generator target source"
means a tritium source used within a neutron generator tube to produce neutrons
for use in well logging applications.

(13) "Well-bore" means a drilled hole in which
wireline-service operations and subsurface-tracer studies are performed.

(14) "Well-logging" means the lowering and
raising of measuring devices or tools which may contain sources of radiation
into well-bores or cavities for the purpose of obtaining information about the
well or adjacent formations.

(15) "Wireline" means a cable containing one or
more electrical conductors which is used to lower and raise logging tools in
the well-bore.

(16) "Wireline-service operations" means any
evaluation or mechanical service which is performed in the well-bore using
devices on a wireline.

No licensee shall perform wireline‑service operations
with a sealed source unless, prior to commencement of the operation, the
licensee has a written agreement with the well operator, well owner, drilling contractor,
or land owner. The written agreement required in this Rule shall certify that:

(1) In the event a sealed source is lodged downhole, a
reasonable effort to recover the source will be made; and

(2) In the event a decision is made to abandon the sealed
source downhole, the requirements of Rule .1324(c) and (d) of this Section
shall be met.

Sources of radiation shall be used, stored, and transported
in such a manner that the transportation requirements of Section .0300 of this
Chapter and the dose limitation requirements of Section .1600 of this Chapter
are met.

(a) Each source of radiation, except accelerators, shall be
provided with a storage and transport container. The container shall be
provided with a lock, or tamper seal for calibration sources, to prevent unauthorized
removal of or exposure to the source of radiation.

(b) Sources of radiation shall be stored in a manner which
will minimize the danger from explosion or fire.

(a) The licensee shall maintain sufficient calibrated and
operable radiation survey instruments at each field station and temporary
jobsite to make physical radiation surveys as required by this Section and by
Section .1600 of this Chapter. Instrumentation shall be capable of measuring beta
and gamma radiation from 0.1 milliroentgen per hour through at least 50
milliroentgens per hour.

(b) Each radiation survey instrument shall be calibrated:

(1) at intervals not to exceed six months and
after each instrument servicing;

(2) at energies and radiation levels
appropriate for use; and

(3) so that accuracy within plus or minus 20
percent of the true radiation level can be demonstrated on each scale.

(c) Calibration records shall be maintained for a period of
three years for inspection by the agency.

(a) Each licensee using sealed sources of radioactive
material shall have the sources tested for leakage. Records of leak test
results shall be kept in units of microcuries and maintained for inspection by
the agency for six months after the next required leak test is performed or
until transfer or disposal of the sealed source.

(b) Tests for leakage shall be performed using a leak test
kit or method approved by the agency in accordance with these Rules and only by
persons specifically authorized to perform such tests by the agency, the U.S.
Nuclear Regulatory Commission, an agreement state, or a licensing state. The
test sample shall be taken from the surface of the source, source holder, or
from the surface of the device in which the source is stored or mounted and on
which one might expect contamination to accumulate. The test sample shall be
analyzed for radioactive contamination, and the analysis shall be capable of
detecting the presence of 0.005 microcurie of radioactive material on the test
sample.

(c) Each sealed source of radioactive material, with the
exception of energy compensation sources (ECSs), shall be tested at intervals
not to exceed six months. Each ECS source that is not exempted from leak
testing pursuant to Paragraph (e) of this Rule shall be tested at intervals not
to exceed three years. In the absence of a certificate from a transferor
indicating that a test has been made prior to the transfer, the sealed source
shall not put into use until tested. If, for any reason, it is suspected that
a sealed source may be leaking, it shall be removed from service immediately
and tested for leakage as soon as practical.

(d) If the test reveals the presence of 0.005 microcurie or
more of leakage or contamination, the licensee shall immediately withdraw the
source from use and shall cause it to be decontaminated, repaired, or disposed
of in accordance with these Rules. A report describing the equipment involved,
the test results, and the corrective action taken shall be filed with the
agency.

(e) The following sources are exempt from the periodic leak
test and notification requirements of this Rule:

(1) hydrogen‑3 (tritium) sources;

(2) sources of radioactive material with a half‑life
of 30 days or less;

(3) sealed sources of radioactive material in
gaseous form;

(4) sources of beta‑ or gamma‑emitting
radioactive material with an activity of 100 microcuries or less; and

(5) sources of alpha- or neutron-emitting
radioactive material with an activity of ten microcuries or less.

Each licensee shall conduct a quarterly physical inventory
to account for all sources of radiation. Records of inventories shall be
maintained for two years from the date of the inventory for inspection by the
agency and shall include the quantities and kinds of sources of radiation, the
location where sources of radiation are assigned, the date of the inventory,
and the name of the individual conducting the inventory.

(a) Each sealed source used in downhole operations, except
those containing radioactive material in gaseous form, shall meet the following
minimum criteria:

(1) be of doubly encapsulated construction;

(2) contain radioactive material whose chemical
and physical forms are as insoluble and non‑dispersible as practical; and

(3) meet the requirements in Paragraphs (b),
(c) and (d) of this Rule.

(b) For a sealed source manufactured on or before July 14,
1989, a licensee may use the sealed source for downhole operations if it meets
the requirements of USASI N5.10-1968, "Classification of Sealed
Radioactive Sources," or the requirements in Paragraphs (c) and (d) of
this Rule.

(c) For a sealed source manufactured after July 14, 1989, a
licensee may use the sealed source for downhole operations if it meets the
oil-well logging requirements of ANSI/HPS N43.6-1977, "Sealed Radioactive
Sources, Classification."

(d) For a sealed source manufactured after July 14, 1989, a
licensee may use the source for downhole operations if the sealed source's
prototype has been tested and found to maintain its integrity after being
subjected to each of the following tests:

(1) The
test source shall be held at -40° C for
20 minutes, 600° C for one hour, and
then be subjected to a thermal shock test with a temperature drop from 600° C to 20°
C within 15 seconds;

(2) A
5 kg steel hammer, 2.5 cm in diameter, shall be dropped from a height of 1
meter onto the test source;

(3) The
test source shall be subjected to a vibration from 25 Hz to 500 Hz at 5 g
amplitude for 30 minutes;

(4) A
1 gram hammer and pin, 0.3 cm pin diameter, shall be dropped from a height of 1
meter onto the test source; and

(5) The
test source shall be subjected to an external pressure of 24,600 pounds per
square inch absolute (1.695x107 pascals).

(e) The requirements of Paragraphs (a) through (d) of this
Rule do not apply to energy compensation sources (ECSs).

(1) Each source, source holder, or logging tool
containing radioactive material shall bear a durable, legible, and clearly
visible marking or label, which has, as a minimum, the standard radiation
caution symbol, without the conventional color requirement, and the following
wording:

CAUTION

RADIOACTIVE
MATERIAL

(2) The marking or labeling required in
Subparagraph (a)(1) of this Rule shall be on the smallest component transported
as a separate piece of equipment.

(3) Each transport container shall have
permanently attached to it a durable, legible, and clearly visible label which
has, as a minimum, the standard radiation caution symbol and the following
wording:

CAUTION

RADIOACTIVE
MATERIAL

NOTIFY CIVIL
AUTHORITIES (OR NAME OF COMPANY)

(4) Each
uranium sinker bar used by the licensee in downhole operations shall be legibly
impressed with the following wording:

CAUTION

RADIOACTIVE
DEPLETED URANIUM

NOTIFY
CIVIL AUTHORITIES (OR NAME OF COMPANY)

(b) The word "danger" may be substituted for the
word "caution" in the signs described in this Rule.

(a) Each licensee shall conduct, at intervals not to exceed
six months, a program of inspection and maintenance of source holders, logging
tools, source handling tools, storage containers, transport containers, and
injection tools to assure proper labeling and proper physical condition. The
licensee shall maintain records of inspection and maintenance for a period of
two years for inspection by the agency.

(b) If any inspection conducted pursuant to Paragraph (a)
of this Rule reveals damage to labeling or components critical to radiation
safety, the licensee shall remove the device from service until repairs have
been made.

(c) The repair, opening, or modification of any sealed
source shall be performed only by persons specifically authorized to do so by
the agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a
licensing state.

(a) No licensee shall permit any individual to act as a
logging supervisor until such individual has:

(1) received, in a course recognized by the
agency, the U.S. Nuclear Regulatory Commission, an agreement state, or a
licensing state, instruction in the subjects outlined in Rule .1325 of this
Section and demonstrated an understanding thereof;

(2) read, received instruction in and
demonstrated an understanding of the rules contained in this Section and the
applicable rules in Sections .0100, .1000, and .1600 of this Chapter or their
equivalent, conditions of appropriate license or certificate of registration,
and the licensee's operating and emergency procedures; and

(3) demonstrated competence to use sources of
radiation, related handling tools, and radiation survey instruments which will
be used on the job.

(b) No licensee shall permit any individual to assist in
the handling of sources of radiation until such individual has:

(1) read or received instruction in the
licensee's operating and emergency procedures and demonstrated an understanding
thereof; and

(2) demonstrated competence to use, under the
personal supervision of the logging supervisor, the sources of radiation,
related handling tools, and radiation survey instruments which will be used on
the job.

(c) The licensee shall provide safety reviews for logging
supervisors and logging assistants at least once during each calendar year.

(d) The licensee shall maintain employee training records
for inspection by the agency for two years following termination of employment.

The licensee's operating and emergency procedures shall
include instructions in at least the following:

(1) handling and use of sources of radiation to be
employed so that no individual is likely to be exposed to radiation doses in
excess of the standards established in Section .1600 of this Chapter;

(2) methods and occasions for conducting radiation
surveys;

(3) methods and occasions for locking and securing
sources of radiation;

(4) personnel monitoring and the use of personnel
monitoring equipment;

(5) transportation to temporary jobsites and field
stations, including the packaging and placing of sources of radiation in
vehicles, placarding of vehicles, and securing sources of radiation during
transportation;

(6) minimizing exposure of individuals in the event of
an accident;

(7) procedure for notifying proper personnel in the
event of an accident;

(a) No licensee shall permit any individual to act as a
logging supervisor or to assist in the handling of sources of radiation unless
each such individual wears a personnel dosimeter that is processed and
evaluated by an accredited National Voluntary Laboratory Accreditation Program
(NVLAP) processor.

(b) Each personnel dosimeter required in Paragraph (a) of
this Rule shall be assigned to and worn by only one individual.

(c) Each film badge shall be replaced at least monthly and
other personnel dosimeters shall be replaced at least quarterly. Each film
badge or other personnel dosimeter shall be submitted for processing within 30
days of replacement.

(d) The licensee shall maintain personnel monitoring
records for inspection until the agency terminates each pertinent license or
registration requiring the record.

During each logging or tracer application, the logging
supervisor or other designated employee of the licensee shall maintain direct
surveillance of the operation to protect against unauthorized or unnecessary
entry into a restricted area, as defined in Section .0100 of this Chapter.

(a) Protective gloves and other appropriate protective
clothing and equipment shall be used by all personnel handling radioactive
tracer material. Precautions shall be taken to avoid ingestion or inhalation
of radioactive material.

(b) No licensee shall cause the injection of radioactive
material as part of a subsurface‑tracer element study without prior
written authorization from any other agency which may regulate or require prior
approval for such injection.

No licensee shall permit above‑ground testing of
particle accelerators, designed for use in well‑logging, which results in
the production of radiation, except in areas of facilities controlled or
shielded so that the applicable requirements of Rules .1604 and .1611 of this
Chapter are met.

(a) The licensee shall make and record radiation surveys
and calculations for each area where radioactive materials are stored.

(b) The licensee shall make and record radiation surveys
and calculations for the radiation levels in occupied positions and on the
exterior of each vehicle used to transport radioactive material. Such surveys
and calculations shall include each source of radiation or combination of
sources to be transported in the vehicle.

(c) After removal of the sealed source from the logging
tool and before departing the jobsite, the licensee shall use the logging tool
detector or a survey meter to assure that the logging tool is free of
contamination.

(d) The licensee shall make and record radiation surveys at
the jobsite or well‑head for each tracer operation, except those using
hydrogen‑3, carbon‑14, and sulfur‑35. These surveys shall
include measurements of radiation levels before and after the operation.

(e) Records required pursuant to Paragraphs (a) through (d)
of this Rule shall include the dates, the identification of individual(s)
making the survey, the identification of survey instrument(s) used, and an
exact description of the location of the survey. The licensee shall maintain
records of these surveys for inspection by the agency for two years after
completion of the survey.

(1) monitor at the surface for the presence of
radioactive contamination with a radiation survey instrument or logging tool
during logging tool recovery operations; and

(2) notify the agency immediately by telephone
if radioactive contamination is detected at the surface or if the source
appears to be damaged.

(c) When it becomes apparent that efforts to recover the
radioactive source will not be successful, the licensee shall:

(1) advise the well‑operator of the rules
of the appropriate state agency with jurisdiction over abandonment and
appropriate method of abandonment, which shall include:

(A) the immobilization and sealing in place of the
radioactive source with a concrete plug;

(B) a means of preventing inadvertent intrusion on the
source, unless the source is not accessible to any subsequent drilling
operations; and

(C) the mounting of a permanent identification plaque,
at the surface of the well, containing the information required by Paragraph
(d) of this Rule;

(2) notify the agency by telephone, giving the
circumstances of the loss and requesting approval of the proposed abandonment
procedures; and

(3) file a written report with the agency
within 30 days of the abandonment, setting forth the following information:

(A) date of occurrence and a brief description of
attempts to recover the source; and

(B) a description of the radioactive source involved,
including radionuclide, quantity, and chemical and physical form;

(i) surface location and identification of well,

(ii) results of efforts to immobilize and set the
source in place,

(iii) depth of the radioactive source,

(iv) depth of the top of the cement plug,

(v) depth of the well, and

(vi) information contained on the permanent
identification plaque.

(d) Whenever a sealed source containing radioactive
material is abandoned downhole, the licensee shall provide a permanent plaque
for posting the well or well‑bore. This plaque shall:

(1) be constructed of long‑lasting
material, such as stainless steel, brass, bronze, or monel;

(2) be at least 7 inches (17 cm) square and 1/8
inch (3mm) thick; and

(3) contain the following information engraved
on its face;

(A) the word "CAUTION";

(B) the radiation symbol without the conventional color
requirement;

(C) the date of abandonment;

(D) the name of the well‑operator or well owner;

(E) the well name and well identification number(s) or
other designation;

(F) the sealed source(s) by radionuclide and quantity
of activity;

(G) the source depth and the depth to the top of the
plug; and

(H) an appropriate warning, depending on the specific
circumstances of each abandonment, which may include:

(i) "Do not drill below plug back depth",

(ii) "Do not enlarge casing", or

(iii) "Do not re-enter the hole" before
contacting the agency at the address in Rule .0111 of this Chapter.

(e) The licensee shall immediately notify the agency by
telephone and subsequently by confirming letter if the licensee knows or has
reason to believe that radioactive material has been lost in or to an
underground potable water source. Such notice shall designate the well
location and shall describe the magnitude and extent of loss of radioactive
material, assess the consequences of such loss, and explain efforts planned or
being taken to mitigate the consequences.

The licensee shall use an energy compensation source (ECS)
which is contained within a logging tool, or other tool components, only if the
ECS contains quantities of licensed material not exceeding 100 microcuries (3.7
MBq).

(1) For
downhole operations utilizing a surface casing for protecting fresh water
aquifers, use of the ECS is subject only to the requirements of Rules .1308,
.1309, .1310, and .1323 of this Section.

(2) For
downhole operations without a surface casing for protecting fresh water
aquifers, use of the ECS is subject only to the requirements of Rules .1303,
.1308, .1309, .1310, .1323, and .1324 of this Section.

(a) The use of a tritium neutron generator target source
containing quantities of radioactive material not exceeding 30 Curies (1,110
MBq) in a well with a surface casing to protect fresh water aquifers is subject
to the requirements of this Section excluding Rules .1303, .1311, and .1324.

(b) The use of a tritium neutron generator target source
which contains quantities of radioactive material exceeding 30 Curies (1,110
MBq) or which is used in a well without a surface casing to protect fresh water
aquifers is subject to the requirements of this Section excluding Rule .1311.

(a) This Section provides for the registration and
regulation of facilities and equipment which employ ultraviolet and other lamps
for the purpose of tanning the skin of the living human body through the
application of ultraviolet radiation.

(b) Except as otherwise provided in this Section, tanning
facilities are exempt from the Rules in Sections .0100 through .1300 of this
Chapter to the extent that such facilities do not receive, own, possess or use
radioactive material or other sources of ionizing radiation as defined in G.S.
104E‑5.

(c) Nothing in this Section shall be interpreted as
limiting the intentional exposure of patients to ultraviolet radiation for the
purpose of treatment or therapy other than skin tanning, provided such
treatment or therapy is supervised by a licensed practitioner of the healing
arts in the lawful practice of their profession, in accordance with the
requirements of their professional licensing board to prescribe and supervise
such treatment.

(1) "Agency" means the North Carolina
Department of Health and Human Services, Division of Health Service Regulation,
Radiation Protection Section.

(2) "Consumer" means any individual who is
provided access to a tanning facility that is required to be registered
pursuant to provisions of this Section.

(3) "Formal Operator Training" is a course of
study approved by this agency as meeting the requirements in Paragraph (i) of
Rule .1418 in this Section.

(4) "Individual" means any human being.

(5) "Inspection" means an official
examination or observation to determine compliance with the rules in this
Section, and orders, requirements, and conditions of the agency.

(6) "Minor" means any individual less than 18
years of age.

(7) "Medical Lamps" means any lamp that is
designed or labeled for medical use only.

(8) "Operator" means any individual
designated by the registrant to operate or to assist and instruct the consumer
in the operation and use of the tanning facility or tanning equipment. Under
this definition, the term "operator," includes any individual who
conducts one or more of the following activities:

(c) informing the consumer of dangers of
ultraviolet radiation exposure including photoallergic reactions and
photosensitizing agents;

(d) assuring that the consumer reads and signs
all forms as required by the rules in this Section;

(e) maintaining required consumer exposure
records;

(f) recognizing and reporting consumer injuries
or alleged injuries to the registrant;

(g) determining the consumer's exposure
schedule;

(h) setting timers which control the duration of
exposure; and

(i) instructing the consumer in the proper use
of protective eyewear.

(9) "Person," as defined in G.S. 104E-5(11),
means any individual, corporation, partnership, firm, association, trust,
estate, public or private institution, group, agency, political subdivision of
this State, any other State or political subdivision or agency thereof, and any
legal successor, representative, agent, or agency of these entities.

(10) "Registrant" means any person who is
registered with the agency as required by provisions of this Section.

(11) "Registration" means registration with the
agency in accordance with provisions of this Section.

(13) "Tanning equipment" means ultraviolet or
other lamps and equipment containing such lamps intended to induce skin tanning
through the irradiation of any part of the living human body with ultraviolet
radiation, e.g., beds, booths, facials, and wands.

(15) "Tanning facility" means any location,
place, area, structure or business that provides consumers access to tanning
equipment. For the purpose of this definition, tanning equipment registered to
different persons at the same location and tanning equipment registered to the
same person, but at separate locations, shall constitute separate tanning
facilities.

(16) "Ultraviolet radiation" means electromagnetic
radiation with wavelengths in air between 200 nanometers and 400 nanometers.

(a) Each person having a tanning facility on the effective
date of this Rule shall apply for registration of such facility no later than
60 days following the effective date of this Rule.

(b) Each person acquiring or establishing a tanning
facility after the effective date of this Rule shall have a certificate of
registration issued by the agency for such facility prior to beginning
operation.

(c) The application required in Paragraphs (a) and (b) of
this Rule shall be completed on forms provided by the agency.

(d) The agency shall require at least the following
information on the forms provided for applying for registration of tanning
facilities:

(1) name, physical address, mail address and
telephone number of the tanning facility;

(2) name(s), mail address(es) and telephone
number(s) of the owner(s) of the tanning facility;

(3) each facility shall submit a copy of the
tanning operator training certificate for each of the tanning facility
operator(s) with the initial application in accordance with the provisions of
the rules of this Section;

(4) the manufacturer(s), model number(s) and
type(s) of ultraviolet lamp(s) or tanning equipment located at the tanning
facility;

(5) name(s) of the tanning equipment
supplier(s), installer(s) and service agent(s);

(6) certification that the applicant has read
and understands the requirements of the rules in this Section, such
certification to be signed and dated by the manager and the owner of the
tanning facility; and

(7) certification that each person operating a
tanning facility shall not allow any individual under 18 years of age to be the
operator of tanning equipment.

(a) Upon determination that an application meets the
requirements of this Section, the agency will issue a certificate of
registration.

(b) The agency may incorporate in the certificate of registration,
at the time of issuance or thereafter by appropriate rule or order, such
additional requirements and conditions with respect to the registrant's
receipt, possession, use and transfer of tanning equipment and tanning
facilities as the agency deems appropriate or necessary.

(a) The registrant shall file applications for renewal in
accordance with Rule .1405 of this Section.

(b) Provided that a registrant files with the agency an
application for renewal in proper form for renewal by August 29 of each
calendar year, such certificate of registration shall not expire pending final
action on the application by the agency.

The registrant shall notify the agency in writing within 30
calendar days after making any change which would render the information
contained in the application for registration or the certificate of
registration no longer accurate.

No person, in any advertisement, shall refer to the fact
that such person or such person's facility is registered with the agency
pursuant to the provisions of this Section, and no person shall state or imply
that any activity under such registration has been approved by the agency.

(a) The agency may deny, suspend or revoke a certificate of
registration applied for or issued pursuant to this Section:

(1) for any material false statement in the
application for registration or in any statement of fact required by provisions
of this Section;

(2) because of conditions revealed by the
application or any report, record, inspection or other means which would
warrant the agency to refuse to grant a certificate of registration on an
original application;

(3) for operation of the tanning facility in a
manner that causes or threatens to cause hazard to the public health or safety;

(4) for failure to allow authorized
representatives of the agency to enter the tanning facility at reasonable times
for the purpose of determining compliance with the provisions of this Section,
conditions of the certificate of registration or an order of the agency;

(5) for violation of or failure to observe any
of the terms and conditions of the certificate of registration, the rules in
this Section, or an order of the agency; or

(6) for failure to pay a fee within 15 days of
becoming delinquent as described in Paragraph (h) of Rule .1423 or for failure
to correct payment of a fee in the form of a check or other instrument which is
uncollectible from the paying institution within the timeframe specified in
accordance with the provisions of the rules of this Section.

(b) Except in cases of willfulness or those in which the
public health, interest or safety requires otherwise, prior to the institution
of proceedings for suspension or revocation of a certificate of registration,
the agency shall:

(1) call to the attention of the registrant, in
writing, the facts or conduct which may warrant such actions, and

(2) provide reasonable opportunity for the
registrant to demonstrate or achieve compliance with all lawful requirements.

(c) Any person aggrieved by a decision by the agency to
deny a certificate of registration or to suspend or revoke a certificate of
registration after issuance may request a hearing under provisions of G.S.
150B, Article 3.

(d) The agency may terminate a certificate of registration
upon receipt of a written request for termination from the registrant.

(a) The registrant shall post the warning sign described in
Paragraph (b) of this Rule within one meter of each tanning station and in such
a manner that the sign is clearly visible to consumers; not obstructed by any
barrier, equipment, or other object; and may be easily viewed by the consumer
before the tanning equipment is energized.

(b) The warning sign in Paragraph (a) of this Rule shall use
upper and lower case letters that are at least seven millimeters and three and
one-half millimeters in height, respectively, and shall state:

DANGER
- ULTRAVIOLET RADIATION

UV  emitting tanning devices have been
classified as "carcinogenic to humans. "

ATTENTION: THIS DEVICE SHALL NOT BE USED BY
PERSONS UNDER 18 YEARS OF AGE.

- Follow instruction.

-
Avoid overexposure. As with natural sunlight, overexposure can cause eye and
skin injury and allergic reactions. REPEATED EXPOSURE MAY CAUSE PREMATURE
AGING OF THE SKIN AND SKIN CANCER.

- Wear protective eyewear.

FAILURE
TO USE PROTECTIVE EYEWEAR MAY RESULT IN SEVERE BURNS OR LONG‑TERM INJURY
TO THE EYES.

Contraindications: This sunlamp
product must not be used if skin lesions or open wounds are present.

Warning: This sunlamp product
should not be used on individuals who have had skin cancer or have a family
history of skin cancer.

-
Medications or cosmetics may increase your sensitivity to the ultraviolet
radiation. Consult a physician before using sunlamp or tanning equipment if
you are using medication or have a history of skin problems or believe yourself
to be especially sensitive to sunlight. Consult your certified tanning
operator for a list of cosmetics and products known to create sensitivity to
light.

- If you do not tan in the sun, you are
unlikely to tan from the use of this product.

- Consumers should report to the
agency any injury for which medical attention is sought or obtained resulting
from the use of registered tanning equipment. This report should be made
within five working days after the occurrence.

(c) Warning signs shall include the current address and
telephone number of the agency: Department of Health and Human Services,
Division of Health Service Regulation, Radiation Protection Section, 1645 Mail
Service Center, Raleigh, NC 27699-1600, (919) 814-2250.

(a) The registrant shall use only tanning equipment
manufactured in accordance with the specifications set forth in 21 Code of
Federal Regulations (CFR) Part 1040, Section 1040.20, and with 21 CFR Part
878.4635, which is herein incorporated by reference, including subsequent
amendments and editions and may be accessed at http://www.ecfr.gov/cgi-bin/ECFR?page=browse.
The standard of compliance shall be the standards in effect at the time of
manufacture as shown on the equipment identification label required by 21 CFR
Part 1010, Section 1010.3. The registrant shall place an additional label on
the bed that states "North Carolina state law prohibits the use of this
device by persons under 18 years of age."

(b) Each assembly of tanning equipment shall be designed
for use by only one consumer at a time.

(c) Each assembly of tanning equipment shall be equipped
with a timer that complies with the requirements of 21 CFR Part 1040, Section
1040.20(c)(2). The maximum timer interval shall not exceed the manufacturer's
maximum recommended exposure time. No timer interval shall have an error
exceeding plus or minus 10 percent of the maximum timer interval for the
product.

(d) Tanning equipment shall include physical barriers to
protect consumers from injury induced by touching or breaking the lamps.

(e) All tanning equipment labeling required in Paragraph
(a) of this Rule shall be easily read by the consumer while in the proximity of
the tanning bed.

(f) The timer intervals shall be numerically indicated on
the face of the timer.

(g) The timer shall not automatically reset and cause
radiation emission to resume for a period greater than the unused portion of
the timer cycle when emission from the tanning device has been interrupted.

(h) Each assembly of tanning equipment shall be provided
with a control on the equipment to enable the consumer to manually terminate
radiation emission from the equipment at any time without disconnecting the
electrical plug or removing any ultraviolet lamp.

(i) The timer for the tanning devices shall be remotely
located outside the room where the tanning equipment is located. The remote
timer shall be set by a certified tanning operator.

(j) The registrant shall ensure that timer tests are
performed annually on each assembly of tanning equipment and documented in
writing for agency review during inspections to ensure the timer is accurate to
within 10 percent as specified in Paragraph (c) of this Rule and the consumer
is able to terminate the radiation manually in accordance with Paragraph (h) of
this Rule.

(k) Medical lamps shall not be used for commercial cosmetic
tanning purposes.

(a) The registrant shall provide protective eyewear to each
consumer for use during any use of tanning equipment.

(b) The protective eyewear in Paragraph (a) of this Rule
shall meet the requirements of 21 CFR Part 1040, Section 1040.20(c)(4).

(c) Tanning facility operators shall instruct the consumer
in the proper utilization of the protective eyewear required by this Rule.

(d) The registrant shall ensure that the protective eyewear
required by this Rule is sanitized before each use and shall not rely upon
exposure to the ultraviolet radiation produced by the tanning equipment itself
to provide such sanitizing.

(a) Prior to initial exposure, the registrant shall provide
each consumer the opportunity to read a copy of the warning specified in Rule
.1414(b) of this Section and have the consumer sign a statement that the
information has been read and understood. For illiterate or visually impaired
persons unable to read, the warning statement shall be read aloud by the operator
to that individual, in the presence of a witness, and the witness and the
operator shall sign the statement.

(b) The registrant shall maintain a record of each
consumer's total number of tanning visits, including dates and durations of
tanning exposures.

(c) The registrant shall submit a written report of injury
for which medical attention was sought or obtained from the use of registered
tanning equipment to the Radiation Protection Section within five business days
after occurrence. The report shall include:

(1) the name of the affected individual;

(2) the name and location of the tanning
facility involved;

(3) the nature of the actual or alleged injury;
and

(4) any other information relevant to the
actual or alleged injury, including the date and duration of exposure and any
documentation of medical attention sought or obtained.

(d) The registrant shall not allow individuals under the
age of 18 to use tanning equipment.

(e) The registrant shall verify by checking legal
identification that includes a driver's license, a passport, or military
identification, each consumer is 18 years of age or older.

(f) The registrant shall not allow minors to remain in the
tanning room while the tanning equipment is in operation.

(g) The registrant shall replace defective or burned out
lamps, bulbs, or filters with a type intended for use in the affected tanning
equipment as specified by the manufacturer's product label and having the same
spectral distribution (certified equivalent lamp).

(h) The registrant shall replace ultraviolet lamps and bulbs
that are not otherwise defective or damaged at such frequency or after such
duration of use as is recommended by the manufacturer of such lamps and bulbs.

(i) The registrant shall certify that all tanning equipment
operators are trained in at least the following:

(1) the requirements of this Section;

(2) procedures for correct operation of the
tanning facility and tanning equipment;

(3) recognition of injury or overexposure to
ultraviolet radiation;

(4) the tanning equipment manufacturer's
procedures for operation and maintenance of the tanning equipment;

(5) the determination of skin type of customers
and determination of duration of exposure to registered tanning equipment; and

(6) emergency procedures to be followed in case
of injury.

(j) The registrant shall allow operation of tanning
equipment only by and in the physical presence of persons who have completed
formal training courses that meet the requirements of Subparagraphs (i)(1) to
(6) of this Rule.

(k) The registrant shall maintain a record of operator
training required in Paragraphs (i) and (j) of this Rule for inspection by
authorized representatives of the agency.

(l) No registrant shall possess, use, operate, or transfer
tanning equipment or their ultraviolet radiation sources in such a manner as to
cause any individual under 18 years of age to be exposed to radiation emissions
from such equipment.

(m) Each registrant shall make available to all employees
current copies of the following documents:

(1) the facility's certificate of registration
with the Radiation Protection Section; and

(2) conditions or documents incorporated into
the registration by reference and amendments thereto.

Applications for registration, reports, notifications, and
other communications required by this Section shall be mailed to the Radiation Protection
Section,1645 Mail Service Center, Raleigh, North Carolina 27699-1600 or
delivered to the agency at its office located at 5505 Creedmoor Road, Suite
100, Raleigh, North Carolina 27612.

Effective August 1, 1993, each person registered pursuant to
Rule .1405 of this Section shall prohibit any person from furnishing tanning
equipment services to their tanning equipment or facility until such person provides
evidence that they are registered with the agency as a provider of services in
accordance with the provisions of Rule .1421 of this Section.

(a) Each person who offers tanning equipment services to
any agency registrant, shall apply for registration of such services with the
agency within 60 days following the effective date of this Rule or, thereafter,
prior to furnishing or offering to furnish any of these services.

(b) The application for registration required in Paragraph
(a) of this Rule shall be completed on an approved agency form.

(c) Persons applying for registration under Paragraph (a)
of this Rule shall certify that they have read and understand the requirements
of the rules in this Section.

(a) Persons registered pursuant to Rule .1421 of this
Section, who sell, lease, transfer, lend, dispose of, assemble or install
tanning equipment in this state shall, within 30 days after each calendar
quarter, notify the agency at the address in Rule .1419 of this Section, of:

(1) whether any tanning equipment was
installed, transferred, or disposed of during the calendar quarter;

(2) the name and address of persons who receive
tanning equipment during the calendar quarter;

(3) the manufacturer, model and serial number
of tanning equipment transferred or otherwise disposed of; and

(4) the date of transfer of any tanning
equipment.

(b) No person shall make, sell, lease, transfer, lend,
repair, assemble, or install tanning equipment or the supplies used in
connection with such equipment unless such supplies and equipment when properly
placed in operation and used shall meet the requirements of the rules in this
Section and the regulations of 21 CFR 1040.20.

(a) Annual fees established in this Rule shall be due on
the first day of July of each year.

(b) Notwithstanding Paragraph (a) of this Rule, when a new
registration is issued by the agency after the first day of July of any year,
the initial fee is due on the date of issuance of the registration.

(c) The initial fee in Paragraph (b) of this Rule shall be
computed as follows:

(1) When any new registration is issued before
the first day of January of any year, the initial fee is the full amount
specified in this Rule; and

(2) When any new registration is issued on or
after the first day of January of any year, the initial fee is one-half of the
amount specified in this Rule.

(d) Each registrant may pay all fees by cash, check, or
money order as follows:

(1) Checks or money orders shall be made
payable to "Radiation Protection Section," and mailed to 1645 Mail
Service Center, Raleigh, NC 27699-1600 or delivered to the agency office at 5505
Creedmoor Road, Suite 100, Raleigh, NC 27612; and

(2) Cash payments shall be made only by
appointment by calling the agency at 919/814-2250 and delivered to the agency
office at 5505 Creedmoor Road, Suite 100, Raleigh, NC 27612.

(e) Within five days after the due dates established in
Paragraphs (a) and (b) of this Rule, the agency shall mail to each registrant who
has not already submitted payment a notice that indicates the due date, the
amount of fees due, and the delinquent date.

(f) Payment of fees established in this Rule shall be delinquent
if not received by the agency within 60 days after the due date specified in
Paragraphs (a) and (b) of this Rule.

(g) If a registrant remits a fee in the form of a check or
other instrument that is uncollectible from the paying institution, the agency
shall notify the registrant by certified mail and allow the registrant 15 days
to correct the matter, including payment of any fee charged to the agency by a
banking institution.

(h) If payment of fees is uncollectible from the paying
institution or not submitted to the agency by the delinquent date, the agency shall
institute legal action to collect.

(i) Annual fees for persons registered pursuant to
provisions of this Section are as listed in the following table:

(a) This Section establishes the procedures, criteria, and
terms and conditions upon which the agency issues site access licenses required
pursuant to the provisions of G.S. 104E‑10.3 and G.S. 104E‑27.

(b) No person shall transfer waste to a disposal facility
located in North Carolina unless such person holds a valid site access license
issued by the agency pursuant to the rules in this Section.

(c) The agency shall issue a site access license to an
applicant only after the agency determines that the applicant:

(1) has implemented best management practices,
including prevention, minimization, reduction, segregation and hold‑for‑decay
storage as required by the rules in this Section; and

(2) is reducing waste volume to the extent
technologically and economically feasible.

(d) Site access licenses issued pursuant to the rules in
this Section shall authorize access only to disposal facilities operated
pursuant to the provisions of G.S. 104G and licensed pursuant to the rules in
Section .1200 of this Chapter. Upon issuance of a site access license pursuant
to the rules in this Section, the agency shall certify to the North Carolina
Low‑Level Radioactive Waste Management Authority that a generator is
reducing waste volume to the extent technologically and economically feasible.

(e) Nothing in this Section or in site access licenses
issued pursuant to this Section shall relieve any person from responsibility
for complying with the conditions of the applicant's existing license for the
possession and use of radioactive materials or any applicable requirements in
the other sections of this Chapter or in state and federal laws and
regulations, including, but not limited to, those of the U.S. Department of
Transportation, the U.S. Nuclear Regulatory Commission, the North Carolina
Department of Transportation, the Southeast Interstate Low‑Level
Radioactive Waste Management Compact, and the North Carolina Low‑Level
Radioactive Waste Management Authority.

(f) The rules in this Section are applicable to generators,
collectors and processors of low‑level radioactive waste which will be
transferred to a low‑level radioactive waste disposal facility located
within the State of North Carolina for disposal.

(g) The rules in this Section are applicable to those waste
forms deemed acceptable according to the North Carolina low‑level
radioactive disposal facility license as issued by the agency. The rules in
this Section shall not be construed to authorize the disposal of any waste that
is not authorized for disposal under Section .1200 of this Chapter.

(h) The agency shall not issue any site access license
prior to January 1, 1995 or prior to the agency issuing an operating license
for a low‑level radioactive waste disposal facility in North Carolina
pursuant to Section .1200 of this Chapter, whichever is the later.

(1) "Carrier" means any person
transporting radioactive waste in North Carolina for the purpose of disposal at
a low‑level radioactive waste disposal facility located in North
Carolina.

(2) "Collector" means any person who
collects or consoli­dates prepared packages of low‑level radioactive
waste from another site access licensee and arranges for the transportation of
such waste to a disposal facility located in North Carolina.

(3) "Generator" means any person who
produces low‑level radioactive waste which will be transferred for
disposal at a low‑level radioactive waste disposal facility located in
North Carolina, including indirect transfer through collectors or processors.

(6) "Manifest" means the document
used for identifying the quantity, composition, origin and destination of low‑level
radioactive waste during its transport to a disposal facility.

(7) "Processor" means any person who
receives low‑level radioactive waste or radioactively contaminated
material from another site access licensee for the purpose of repackaging or
treatment, including, but not limited to, compaction, incineration,
decontamination or resource recovery, prior to transfer to a disposal facility
located in North Carolina.

(8) "Radioactive material license"
means any license issued by the agency, an agreement state or the U. S. Nuclear
Regulatory Commission which authorizes activities which may generate waste.

(9) "Shipment" means the total low‑level
radioactive waste transported in a single conveyance as defined in 49 CFR §
173.403.

(10) "Shipper" means any person who
holds a valid site access license and prepares low‑level radioactive
waste for transport to a low‑level radioactive waste disposal facility
located in North Carolina.

(11) "Site access license" means a
license issued pursuant to the rules in this Section.

(12) "Solidifying" means that process
by which liquid wastes or wastes containing liquids are converted into an
acceptable stable form as defined in Rule .1651 of this Chapter.

(a) No person shall ship or transfer waste to a low‑level
radioactive waste disposal facility located in North Carolina, except as
authorized by a valid site access license issued, prior to shipment or
transfer, pursuant to the rules in this Section.

(b) A separate site access license is required for each
generator, collector and processor facility from which waste, which will be
transferred to a low‑level radioactive waste disposal facility located in
North Carolina, is shipped.

(1) the U.S. Nuclear Regulatory Commission has
granted emergency access as authorized under the Low‑Level Radioactive
Waste Policy Amendments Act of 1985, provided that access shall be limited to
that granted by the U.S. Nuclear Regulatory Commission and complies with Rule
.1517 of this Section; or

(2) access has been granted by the Southeast
Compact Commission in accordance with provisions of G.S. 104F and complies with
all rules of this Section.

(a) Each applicant for a site access license shall file a
completed agency application form. The completed application shall include the
following information:

(1) name, address, telephone number, and
description of the business of the applicant;

(2) a list of radioactive material licenses
issued to the applicant along with the name of the regulatory agency that
issued each license;

(3) name, address and telephone number of the
facility for which a site access license is requested;

(4) name and telephone number of the person who
is responsible for the applicant's waste management plan;

(5) organization chart which depicts the
relationship among senior level management, managers of waste generating and
waste management activities, and the person identified in Subparagraph (a)(4)
of this Rule;

(6) general transportation routing information,
within the State of North Carolina, of waste shipments, including but not
limited to waste transported for processing and waste transported for disposal
at the North Carolina disposal facility;

(7) certifications and additional information
required by other applicable rules in this Section; and

(8) other relevant information necessary for the
agency to determine compliance with these Rules.

(b) The agency may at any time after the filing of the
application, and before the expiration of a site access license, require
further statements and information to enable the agency to determine whether to
grant, deny, modify, suspend or revoke a site access license.

(c) Each application for a site access license shall be
signed by the manager of the facility for which the site access license is
requested or by his designee, provided that such designation shall be confirmed
to the agency, in writing, by the manager.

(d) Except as provided in Paragraph (e) of this Rule,
applications and documents submitted to the agency are public documents and
shall be made available for public inspection.

(e) Notwithstanding Paragraph (d) of this Rule, the
applicant may request that specific parts of the application and supporting
documents which consist of proprietary information be withheld from public
inspection. Such request shall include a detailed justification for each part
which is proposed to be withheld. The agency may approve such requests in
whole or in part, if the agency determines that public disclosure is not
required in the public interest and would adversely affect the interest of the
applicant. All agency approvals shall be made in writing and shall be
available for public inspection.

(f) The applicant shall submit the application for a site
access license required by this Section to the agency at the address in Rule
.0111 of this Chapter.

(g) If the facility is not located in North Carolina, the
applicant shall also submit a copy of the application to the state radiation
protection regulatory agency in, or if none, to such other state agency
designated by the state in which the facility is located.

(h) If the facility is licensed by the U.S. Nuclear
Regulatory Commission, the applicant shall also submit a copy of the
application to the U.S. Nuclear Regulatory Commission.

If the applicant for a site access license is a waste
generator, the application required in Rule .1504 of this Section shall include
the following additional information:

(1) general description of the activities which involve
the production of waste along with the radioactive material license numbers
under which such activities are conducted;

(2) general description of existing on‑site waste
management, to include facilities, equipment, procedures and programs for:

(a) limiting the production of contaminated
material and contained radioactivity which must be managed, and the estimated
annual impact on the amount of material and radioactivity;

(b) reducing the volume and contained
radioactivity of waste which will be shipped, or transferred to collectors for
shipment, to off‑site disposal facilities, and the estimated annual
impact on the volume and contained radioactivity shipped or transferred;

(c) classifying, stabilizing, solidifying
liquids, packaging and monitoring waste prior to shipment or transfer to a
collector for shipment to a disposal facility located in North Carolina; and

(d) quality assurance and quality control;

(3) description of existing off‑site waste
management, to include:

(a) name, address, telephone number, type of
processing and radioactive material license number of each off‑site
processor to which waste referenced in Sub-Item (2)(b) of this Rule will be
shipped; and

(b) estimated annual impact on the volume and
contained radioactivity which will ultimately be shipped to a disposal facility
located in North Carolina;

(4) description of planned changes in on‑site and
off‑site management described in Items (2) and (3) of this Rule, to
include anticipated date for implementation and estimated annual impact on the
volume and contained radioactivity of waste which will be disposed at a
disposal facility located in North Carolina;

(5) history of off‑site waste disposal for the
past five years, to include:

(a) identification of all disposal facilities
which received waste for disposal; and

(b) the total volume and contained radioactivity
of waste disposed each year;

(6) description of the projected waste which will be
disposed at a disposal facility located in North Carolina for each of the next
five years, to include the projected volume and contained radioactivity for
Class A, Class B and Class C waste;

(7) any regulatory notices of violation and corrective
actions related to on‑site and off‑site management described in
Items (2) and (3) of this Rule during the past five years; and

(8) description of the applicant's notification and
emergency response program in the event of accidents during transportation.
This description shall include the qualifications and responsibilities of the
driver.

(iii) ensuring that waste shipped to a waste
disposal facility located in North Carolina is collected only from persons who
hold a currently valid site access license issued pursuant to the rules in this
Section;

(iv) ensuring that packages, labels, vehicles,
placards, and radiation and contamination levels comply with applicable state
and federal regulations;

(v) quality assurance and quality control;

(vi) notifications and emergency response in the
event of accidents during transportation, including the qualifications and
responsibilities of the driver;

(3) a list of the waste processing and disposal
facilities to which collected waste was shipped during the past five years; and

(4) any regulatory notices of violation and corrective
actions related to on‑site and off‑site management described in
Items (2) and (3) of this Rule during the past five years.

If the applicant for a site access license is a waste
processor, the application required in Rule .1504 of this Section shall include
the following additional information:

(1) the applicable information required by Rule .1505
of this Section, if the waste processor is located within the Southeast Compact
and generates waste which will be disposed at a disposal facility located in
North Carolina;

(2) a list of the states from which waste may be
received for processing;

(3) description of waste processing services and
management, to include:

(a) the radioactive material license numbers
under which such activities are conducted;

(b) the types of waste processing services,
description of the wastes which may be processed and the estimated impact of
the processing on:

(i) volume and contained radioactivity of
processed waste which will be shipped to off‑site disposal facilities;
and

(ii) ensuring that processed waste shipped to a
waste disposal facility located in North Carolina is waste generated by persons
who hold a currently valid site access license issued pursuant to the rules in
this Section;

(iii) classifying, stabilizing, solidifying
liquids, packaging and monitoring waste prior to shipment, or transfer to a
collector or the generator for shipment, to a disposal facility located in
North Carolina;

(iv) preparing manifests and correlating
manifests with the original manifests prepared by the waste generators for
processed waste which will be disposed at a disposal facility located in North
Carolina;

(v) ensuring that packages, labels, and
radiation and contamination levels comply with applicable state and federal
regulations;

(vi) quality assurance and quality control; and

(vii) ensuring that waste generated by the
processor is residual waste resulting from the processor's activities and that
such waste can not be identified as waste attributed to a particular generator;

(4) a list of the waste disposal facilities to which
processed waste was shipped during the past five years;

(5) for each of the past five years, a summary of the
volumes and types of waste processed and the resulting volumes of processed
waste shipped off‑site;

(6) description of the applicant's notification and
emergency response program in the event of accidents during transportation.
This description shall include the qualifications and responsibilities of the
driver; and

(7) any regulatory notices of violation and corrective
actions related to on‑site and off‑site management described in
Items (2) and (3) of this Rule during the past five years.

(a) Each shipper who prepares packages of waste for
shipment to a disposal facility located in North Carolina shall certify that:

(1) the packages and contained waste comply
with all disposal site restrictions and acceptance criteria and with all
applicable state and federal laws and regulations including, but not limited
to, those governing manifests, labeling, radiation and contamination levels and
package design and performance; and

(2) the prior notification required by Rule
.1509 of this Section will be made for each shipment of waste.

(b) Each shipper who transports packages of waste, using
shipper‑controlled drivers or vehicles, to a disposal facility located in
North Carolina shall certify that such transportation, transport vehicles,
placarding, and driver training will comply with all applicable disposal
facility license conditions and acceptance criteria, and state and federal laws
and regulations.

(c) The certification requirements specified in this Rule
shall be in written form and shall accompany each separate shipment of waste
shipped to the North Carolina disposal facility.

(d) The disposal facility operator shall provide to the
agency for each shipment of accepted waste at the North Carolina disposal
facility a copy of the written certification that accompanied each shipment of
waste.

(a) Prior to each shipment of waste to a disposal facility
located in North Carolina, both the agency and the facility operator shall
receive written notice from the shipper no less than 72 hours and no earlier
than 30 days before the expected date of arrival of the shipment at the
disposal facility.

(b) The prior notification required in Paragraph (a) of
this Rule shall be filed on a "Radioactive Waste Shipment Prior
Notification Form", or appropriate form(s) approved by the agency and
which shall include the following:

(1) name and address of shipper;

(2) person responsible for waste shipment,
including:

(A) name;

(B) title; and

(C) telephone number;

(3) site access license number of the shipper and
the site access license number of any other generator, processor, or collector
involved with the waste;

(4) shipment identification number originated
by and obtained from the disposal facility operator;

(5) location from which waste will be shipped;

(6) name and address of consignee;

(7) scheduled date of departure of shipment;

(8) estimated date of arrival of shipment;

(9) carrier;

(10) trailer number and owner, if available;

(11) type of transport vehicle;

(12) transportation route;

(13) type of package or cask model number;

(14) type of container in cask;

(15) package or cask specification;

(16) complete waste description;

(17) physical and chemical form;

(18) total number of packages;

(19) prominent radionuclides;

(20) total curies;

(21) waste class and stability;

(22) total cubic feet;

(23) U.S. Department of Transportation Sub Type ,
such as Low Specific Activity;

(24) U.S. Department of Transportation
Identification Number;

(25) indication of highway route controlled
quantity;

(26) such other relevant information necessary
for the agency to determine compliance with these Rules;

(27) signature block certifying validity of
information provided; and

(28) signature block for consignee.

(c) The shipper shall immediately notify the agency and the
facility operator of any cancellations or changes in the prior notification
form which may occur immediately prior to the shipment departing from the
facility enroute to the disposal facility; including, but not limited to the
date of arrival, total number of packages, curie content, volume, or waste
classification. This notification may be transmitted via documented telephone
conversation, or the use of telecopy or facsimile machine.

(d) No shipment of waste to a disposal facility in North
Carolina shall commence until the shipper has received and documented
confirmation from the operator of the disposal facility that the information
provided on the prior notification form and any changes, as identified by the
requirements in Paragraph (c) of this Rule, comply with the conditions of the
facility operator's license.

(e) With each separate shipment of waste to the North
Carolina disposal facility the shipper shall provide to the carrier a copy of
the prior notification form required by Paragraph (a) of this Rule for delivery
to the disposal facility operator. This copy shall reflect any changes made
pursuant to Paragraph (c) of this Rule.

(f) Following the acceptance of each shipment of waste at
the North Carolina disposal facility, the disposal facility operator shall sign
the prior notification form and submit signed copies to the agency and to the
shipper within one week after acceptance.

(g) The prior notification form required in this Rule is in
addition to the manifest requirements in Rule .1510 of this Section.

(a) A manifest completed by the shipper, on forms supplied
by the disposal facility operator, shall accompany each shipment of waste to a
disposal facility located in North Carolina and shall include all information
and certifications required by the rules in this Chapter and the disposal
facility operator's license conditions.

(b) If the shipper is a waste processor, the manifest
required in Paragraph (a) of this Rule shall reflect any consolidation of the
original waste generator manifests and any residual waste generated by the
processor.

(a) The purpose of this Rule is to defray expenses incurred
by the State of North Carolina for any project or activity for emergency
response to and decontamination of radioactive waste transportation accidents
involving the possible or actual release of radioactive materials and to defray
the costs to the State for performing or supervising decontamination and to
otherwise protect the public health and safety.

(b) The agency shall not issue a site access license until
the applicant has satisfied the surety bond or insurance requirements in this
Rule.

(c) The applicant must deposit and maintain with the agency
a minimum cash or corporate surety bond in the amount of five hundred thousand
dollars ($500,000), or provide the agency satisfactory evidence of liability
insurance or provide a certificate of insurance as an added insured on a policy
held by a site access licensee that satisfies the insurance requirements of
this Rule.

(1) For purposes of the rules in this Section,
liability insurance shall mean coverage of one million ($1,000,000) per
occurrence and five million ($5,000,000) aggregate;

(2) Any insurance carried pursuant to Section
.2210 of Title 42 of the United States Code and 10 CFR 140 shall be sufficient
to meet the requirements of this Rule; and

(3) Liability insurance shall be specific to
the packaging, transportation, storage and delivery of radioactive waste.

(d) An applicant maintaining liability insurance for the
purpose of this Rule shall provide to the agency a certificate of insurance
from their insurer indicating the policy number, limits of liability, policy
date and specific coverage for packaging, transportation, storage and delivery
of radioactive waste.

(e) A cash or corporate surety bond previously posted for
the purposes of this Rule shall be returned to the site access licensee upon
written notification to the agency of his intention to cease shipments of
radioactive waste to the North Carolina disposal facility, provided such bond
shall be returned only after the last such shipment has been accepted safely at
the disposal facility.

(f) Agencies of the State of North Carolina shall not be
subject to the requirements of this Rule.

(g) Notwithstanding Paragraph (c) of this Rule, the agency
may require greater surety bond or insurance, based on agency analysis of the
potential cost to the State for the activities in Paragraph (a) of this Rule,
provided that:

(1) the agency shall provide written
notification to the site access licensee or applicant for a site access license
of the proposed amount and agency analysis; and

(2) the agency shall provide 30 days from the
date of notification for the site access licensee or applicant for a site
access license to submit a proposed alternate amount and basis for
consideration by the agency.

(h) The indemnitor on such a bond or an insurance company
for any purpose of this Rule shall be licensed to do business in the State of
North Carolina.

(a) The purpose of this Rule is to define those elements
which may constitute a sound waste management program and to require each
applicant for a site access license or renewal of an existing site access
license to explain how each element is implemented or, if not implemented, why
its omission is justified.

(b) Those elements and sub‑elements which constitute
sound waste management practices include, but are not limited to, the
following:

(c) The applicant shall indicate the extent to which each
of the elements and sub‑elements listed in Paragraph (b) of this Rule and
any other waste management practices are being employed in the applicant's
waste management program.

(d) For each element and sub‑element listed in
Paragraph (b) of this Rule that is not employed in the applicant's waste
management program, the applicant shall provide a justification for its
omission which shall include an evaluation of the omission in accordance with
the ALARA principle and shall include a schedule for implementation, if future
implementation is planned.

(a) The agency will issue a site access license only after
the following determinations are made and upon agency certification to the
North Carolina Low‑Level Radioactive Waste Management Authority that the
generator is reducing waste volume to the extent technologically and
economically feasible:

(1) The applicant has submitted a license
application which adequately demonstrates the applicant's ability to satisfy
all requirements in the rules of this Section;

(2) The applicant has a waste management
program which incorporates best management practices, including prevention,
minimization, reduction, segregation, and hold for decay storage, as provided
in Rule .1512 of this Section;

(3) The applicant is reducing waste volume and
contained radioactivity to the extent technologically and economically
feasible, including off‑site processing, before waste is disposed at a
disposal facility located in North Carolina, or has made a commitment to institute
such methods in accordance with a timetable specifically approved by the
agency;

(4) The applicant has filed the bonds,
insurance or other security with the agency as required in Rule .1511 of this
Section; and

(5) The applicant will ship waste to a disposal
facility located in North Carolina only when such waste is generated in the
Southeast Compact region, except as provided otherwise for waste generated by
waste processors and authorized pursuant to Item (1) of Rule .1507 of this
Section or as provided in Rule .1503(c) of this Section.

(b) Except as provided in Rules .1514 and .1517 of this
Section, a site access license shall be effective for a period of five years
subject to payment of applicable fees imposed by the rules in Section .1100 of
this Chapter.

(c) Notwithstanding the provisions of Paragraph (b) of this
Rule, any site access license is subject to modification, revocation or
suspension in accordance with provisions of Rule .1516 of this Section.

(d) The licensee shall apply for amendment of the site
access license in accordance with Rule .1515 of this Section prior to making
changes in the waste management program described in the license application
that would diminish the effectiveness of the waste management program,
including but not limited to, any change resulting in an increase of waste
volume and radiation exposure.

(e) If any information required by Paragraph (a) of Rule
.1504 changes, the licensee shall notify the agency of such changes in writing
no later than 60 days after the change and file an application for amendment,
if so directed by the agency.

(a) An application for renewal of a site access license
shall be filed in accordance with Rule .1504 of this Section.

(b) When a site access licensee has filed an application in
proper form for renewal not less than 30 days prior to expiration of his
existing license, the existing site access license shall not expire until the
agency has taken final action on the application.

(c) When a site access licensee files an application for
renewal less than 30 days prior to expiration of his existing site access
license, the licensee shall not have access to a disposal facility located in
North Carolina after the expiration date until the agency has issued final
approval of the application.

(d) As a precondition for renewal of a site access license,
the applicant shall satisfy the provisions of Rule .1512 of this Section.

(a) An application for amendment of a site access license
shall be filed in accordance with Rule .1504 of this Section and shall specify
the manner in which the licensee desires the site access license to be amended
and the grounds for the amendment.

(b) In determining whether an amendment to a site access
license will be approved, the agency shall apply the criteria set forth in Rule
.1513 of this Section.

(a) The agency may grant temporary or emergency access to a
disposal facility located in North Carolina to a generator in the Southeast
Compact region, only if:

(1) access is necessary in order to eliminate
an immediate and serious threat to the public health and safety;

(2) the determination is made that the threat
cannot be mitigated by any other alternative consistent with the public health
and safety, including ceasing the activities that generate the waste; and

(3) the waste form and content of the waste to
be disposed, meets all acceptability requirements as stated in the facility
operator's license.

(b) The agency may grant temporary or emergency access to a
disposal facility located in North Carolina to a generator outside the
Southeast Compact region, only after:

(1) Such access has been granted by the U.S.
Nuclear Regulatory Commission in accordance with applicable provisions of
federal regulations and of the Low‑Level Radioactive Waste Policy Amendments
Act of 1985; and

(2) The agency has reviewed the U.S. Nuclear
Regulatory Commission's decision to grant temporary or emergency access.

(c) Temporary or emergency access to a disposal facility
located in North Carolina is subject to the applicable site access licensing
requirements in this Section and to the fee requirements in Section .1100 of
this Chapter.

(d) Notwithstanding the provisions of Rule .1513 of this
Section, a site access license, authorizing temporary or emergency access,
shall be effective only for the period of time and the specific waste for which
temporary or emergency access was granted.

(a) The rules in this Section establish standards for
protection against ionizing radiation resulting from activities conducted under
licenses and registrations issued by the agency pursuant to the rules in this
Chapter.

(b) It is the purpose of the rules in this Section to
control the receipt, possession, use, transfer, and disposal of sources of
radiation by any licensee or registrant in such a manner that the total dose to
an individual, including doses resulting from all sources of radiation other
than background radiation, does not exceed the standards for protection against
radiation prescribed in the rules in this Section. However, nothing in this
Section shall be construed as limiting actions that may be necessary to protect
health and safety.

(c) The rules in this Section apply to persons licensed or
registered by the agency to receive, possess, use, transfer, or dispose of
radioactive material or other sources of radiation. The limits in this Section
do not apply to doses due to background radiation, to exposure of patients to
radiation for the purpose of medical diagnosis or therapy, to voluntary
participation in medical research programs, or to exposure from individuals
administered radioactive material and released in accordance with Rule .0358 of
this Chapter.

(d) Nothing in this Section shall relieve a licensee
engaged in operation of a radioactive waste disposal facility, as defined in
Rule .0104 of this Chapter, from responsibility for complying with the
requirements in Section .1200 of this Chapter.

(e) Effective January 1, 1994 all licensees and registrants
shall comply with the rules in this Section and cease to comply with the requirements
in Section .0400 of this Chapter, except as provided otherwise in Rule .1602 of
this Section.

(a) If the requirements of this Section are more
restrictive than a license or registration condition established prior to
January 1, 1994, the licensee or registrant shall comply with this Section
unless exempted by Paragraph (c) of this Rule.

(b) If any existing license or registration condition is
more restrictive than a requirement in this Section, the licensee or registrant
shall comply with such condition until there is a license or registration
amendment or license or registration renewal that modifies or removes the
condition.

(c) If a license or registration condition established
prior to January 1, 1994 exempts a licensee or registrant from a requirement in
this Section, the exemption shall remain in effect until there is a license or
registration amendment or license or registration renewal that modifies or
removes the condition.

(a) Each licensee or registrant shall develop, document,
and implement a radiation protection program commensurate with the scope and
extent of licensed or registered activities and sufficient to ensure compliance
with the provisions of this Section. Recordkeeping requirements relating to
these programs are provided in Rule .1636 of this Section.

(b) The licensee or registrant shall use procedures and
engineering controls based upon sound radiation protection principles to
achieve occupational doses and doses to members of the public and releases of
radioactive materials in effluents to unrestricted areas that are as low as is
reasonably achievable (ALARA).

(c) The licensee or registrant shall annually review the
radiation protection program content and implementation.

(d) To implement the ALARA requirements of Paragraph (b) of
this Rule, and notwithstanding the requirements of Rule .1611 of this Section,
a constraint on air emissions of radioactive material to the environment,
excluding Radon-222 and its daughters, shall be established by licensees such
that the individual member of the public likely to receive the highest dose
will not be expected to receive a total effective dose equivalent in excess of
0.01 rem (0.1 mSv) per year from these emissions. If a licensee subject to
this requirement exceeds this dose constraint, the licensee shall report the
exceedance as provided in Rule .1647 of this Section and promptly take
appropriate corrective action to ensure against recurrence.

(a) A licensee or registrant shall limit the occupational
dose to individual adults, except for planned special exposures as provided in
Rule .1608 of this Section, to the following dose limits:

(1) an annual limit, which is the more limiting
of:

(A) the total effective dose equivalent being equal to
five rems (0.05Sv); or

(B) the sum of the deep-dose equivalent and the committed
dose equivalent to any individual organ or tissue other than the lens of the
eye being equal to 50 rems (0.5 Sv); and

(2) the annual limits to the lens of the eye,
the skin of the whole body, and the skin of the extremities which are:

(A) an eye dose equivalent of 15 rems (0.15 Sv); and

(B) a shallow-dose equivalent of 50 rems (0.50 Sv) to
the skin of the whole body or to the skin of any extremity.

(b) Doses received in excess of the annual limits,
including doses received during accidents, emergencies, and planned special
exposures, shall be subtracted from the limits for planned special exposures
that the individual may receive during the current year and during the
individual's lifetime. Dose limits for planned special exposures are provided
in Item (5) of Rule .1608 of this Section.

(c) When the external exposure is determined by measurement
with an external personal monitoring device, the deep-dose equivalent must be
used in place of the effective dose equivalent unless the effective dose
equivalent is determined by a dosimetry method approved by the agency as
consistent with this Chapter. The assigned deep-dose equivalent must be for
the part of the body receiving the highest exposure. The assigned shallow-dose
equivalent must be the dose averaged over the contiguous 10 square centimeters
of skin receiving the highest exposure. The deep-dose equivalent, lens-dose
equivalent, and shallow-dose equivalent may be assessed from surveys or other
radiation measurements for the purpose of demonstrating compliance with the
occupational dose limits if the individual monitoring device was not in the
region of highest potential exposure or the results of individual monitoring
are unavailable.

(d) Derived air concentration (DAC) and annual limit on
intake (ALI) values are presented in Table 1 of Appendix B to 10 CFR 20.1001 -
20.2401 and may be used to determine the individual's dose and to demonstrate
compliance with the occupational dose limits.

(e) In addition to the annual dose limits, the licensee
shall limit the soluble uranium intake by an individual to 10 milligrams in a
week in consideration of chemical toxicity. Requirements for annual limits on
intake for uranium are provided in Appendix B to 10 CFR 20.1001 - 20.2401.

(f) The licensee or registrant shall reduce the dose that
an individual may be allowed to receive in the current year by the amount of prior
or current occupational dose received while employed by any other person.
Requirements for determining prior occupational exposure are provided in Rule
.1638(e) of this Section.

(a) If the licensee is required to monitor under both Items
(1) and (2) of Rule .1614 of this Section, the licensee shall demonstrate
compliance with the dose limits by summing external and internal doses. If the
licensee is required to monitor only by Rule .1614(1) of this Section or only
by Rule .1614(2) of this Section, then summation is not required to demonstrate
compliance with the dose limits. The licensee may demonstrate compliance with
the requirements for summation of external and internal doses by meeting one of
the conditions specified in Paragraph (b) of this Rule and the conditions in
Paragraphs (c) and (d) of this Rule. The dose equivalents for the lens of the eye,
the skin, and the extremities are not included in the summation, but are
subject to separate limits.

(b) If the only intake of radionuclides is by inhalation,
the total effective dose equivalent limit is not exceeded if the sum of the
deep-dose equivalent divided by the total effective dose equivalent limit, and
one of the following, does not exceed unity:

(1) the sum of the fractions of the inhalation
ALI for each radionuclide, or

(2) the total number of derived air
concentration-hours (DAC-hours) for all radionuclides divided by 2,000, or

(3) the sum of the calculated committed
effective dose equivalents to all significantly irradiated organs or tissues
(T) calculated from bioassay data using appropriate biological models and
expressed as a fraction of the annual limit. For the purposes of this Rule an
organ or tissue is deemed to be significantly irradiated if, for that organ or
tissue, the product of the weighing factors, wT, and the committed dose
equivalent, HT,50 per unit intake is greater than 10 percent of the maximum
weighted value of HT,50 (i.e., wTHT,50) per unit intake for any organ or
tissue.

(c) If the occupationally exposed individual also receives
an intake of radionuclides by oral ingestion greater than 10 percent of the
applicable oral ALI, the licensee shall account for this intake and include it
in demonstrating compliance with the limits.

(d) The licensee shall evaluate and, to the extent
practical, account for intakes through wounds or skin absorption. The intake
through intact skin has been included in the calculation of DAC for hydrogen-3
and does not need to be further evaluated.

Licensees shall, when determining the dose from airborne
radioactive material, include the contribution to the deep-dose equivalent, eye
dose equivalent, and shallow-dose equivalent from external exposure to the
radioactive cloud. Airborne radioactivity measurements and DAC values shall
not be used as the primary means to assess the deep-dose equivalent when the
airborne radioactive material includes radionuclides other than noble gases or
if the cloud of airborne radioactive material is not relatively uniform. The
determination of the deep-dose equivalent to an individual shall be based upon
measurements using instruments or individual monitoring devices.

(a) For purposes of assessing dose used to determine
compliance with occupational dose equivalent limits, the licensee shall, when
required by Rule .1614 of this Section, take suitable and timely measurements
of:

(1) concentrations of radioactive materials in
air in work areas; or

(2) quantities of radionuclides in the body; or

(3) quantities of radionuclides excreted from
the body; or

(4) combinations of these measurements.

(b) Unless respiratory protective equipment is used, as
provided in Rule .1620 of this Section, or the assessment of intake is based
on bioassays, the licensee shall assume that an individual inhales radioactive
material at the airborne concentration in which the individual is present.

(c) When specific information on the physical and
biochemical properties of the radionuclides taken into the body or the behavior
of the material in an individual is known, the licensee may:

(1) use that information to calculate the
committed effective dose equivalent, provided the licensee documents that
information in the individual's record; and

(2) upon prior approval of the agency, adjust
the DAC or ALI values to reflect the actual physical and chemical
characteristics of airborne radioactive material (e.g., aerosol size
distribution or density); and

(3) separately assess the contribution of
fractional intakes of Class D, W, or Y compounds of given radionuclide to the
committed effective dose equivalent. Requirements for annual limits on intake
are provided in Appendix B to 10 CFR §§ 20.1001 - 20.2401.

(d) If the licensee chooses to assess intakes of Class Y
material using the measurements given in Subparagraph (a)(2) or (3) of this
Rule, the licensee may delay the recording and reporting of the assessments for
periods up to seven months, unless otherwise required by Rules .1646 or .1647
of this Section, in order to permit the licensee to make additional
measurements basic to the assessments.

(e) If the identity and concentration of each radionuclide
in a mixture are known, the fraction of the DAC applicable to the mixture for
use in calculating DAC-hours shall be either:

(1) the sum of the ratios of the concentration
to the appropriate DAC value (e.g., D, W, Y) from Appendix B to 10 CFR §§ 20.1001
- 20.2401 for each radionuclide in the mixture; or

(2) the ratio of the total concentration for
all radionuclides in the mixture to the most restrictive DAC value for any
radionuclide in the mixture.

(f) If the identity of each radionuclide in a mixture is
known, but the concentration of one or more of the radionuclides in the mixture
is not known, the DAC for the mixture shall be the most restrictive DAC of any
radionuclide in the mixture.

(g) When a mixture of radionuclides in air exists, licensees
may disregard certain radionuclides in the mixture if:

(1) the licensee uses the total activity of the
mixture in demonstrating compliance with the dose limits in Rule .1604 of this
Section and in complying with the monitoring requirements in Rule .1614 of this
Section;

(2) the concentration of any radionuclide
disregarded is less than 10 percent of its DAC; and

(3) the sum of these percentages for all of the
radionuclides disregarded in the mixture does not exceed 30 percent.

(h) In order to calculate the committed effective dose
equivalent, the licensee may assume that the inhalation of one ALI, or an
exposure of 2,000 DAC-hours, results in a committed effective dose equivalent
of five rems (0.05 Sv) for radionuclides that have their ALIs or DACs based on
the committed effective dose equivalent.

(i) When the ALI and the associated DAC are determined by
the nonsto­chastic organ dose limit of 50 rems (0.5 Sv), the stochastic ALI,
which is the intake of radionuclides that would result in a committed effective
dose equivalent of five rems (0.05 Sv), is listed in parentheses in Table 1 of
Appendix B to 10 CFR §§ 20.1001 - 20.2401. In this case, the licensee may, as
a simplifying assumption, use the stochastic ALIs to determine committed
effective dose equivalent. However, if the licensee uses the stochastic ALIs,
the licensee shall also demonstrate that the limit in Part (a)(1)(B) of Rule
.1604 of this Section is met.

A licensee or registrant may authorize an adult worker to
receive doses in addition to and accounted for separately from the doses
received under the limits specified in Rule .1604 of this Section provided that
each of the following conditions is satisfied:

(1) The licensee or registrant authorizes a planned
special exposure only in an exceptional situation when alternatives that might
avoid the dose estimated to result from the planned exposure are unavailable or
impractical.

(2) The licensee or registrant, and employer if the
employer is not the licensee or registrant, specifically authorizes the planned
special exposure, in writing, before the exposure occurs.

(3) Before a planned special exposure, the licensee or
registrant ensures that the individuals involved are:

(a) informed of the purpose of the planned
operation;

(b) informed of the estimated doses and
associated potential risks and specific radiation levels or other conditions
that might be involved in performing the task; and

(c) instructed in the measures to be taken to
keep the dose ALARA considering other risks that may be present.

(4) Prior to permitting an individual to participate in
a planned special exposure, the licensee or registrant ascertains prior doses
as required by Rule .1638(b) of this Section during the lifetime of the
individual for each individual involved.

(5) Subject to Rule .1604(b) of this Section, the
licensee or registrant does not authorize a planned special exposure that would
cause an individual to receive a dose such that the individual's dose from all
planned special exposures and all doses in excess of the limits would exceed:

(a) the numerical values of any of the dose
limits in Rule.1604(a) of this Section in any year; and

(b) five times the annual dose limits in Rule
.1604(a) of this Section during the individual's lifetime.

(6) The licensee or registrant maintains records of the
conduct of a planned special exposure in accordance with Rule .1639 of this
Section and submits a written report in accordance with Rule .1648 of this
Section.

(7) The licensee or registrant records the best
estimate of the dose resulting from the planned special exposure in the
individual's record and informs the individual, in writing, of the dose within
30 days from the date of the planned special exposure. The dose from planned
special exposures is not to be considered in controlling future occupational
dose of the individual under Rule .1604(a) of this Section but is to be
included in evaluations required by Items (4) and (5) of this Rule.

(a) The licensee or registrant shall ensure that the dose
equivalent to an embryo/fetus during the entire pregnancy, due to occupational
exposure of a declared pregnant woman, does not exceed 0.5 rem (5 mSv).
Recordkeeping requirements for doses to an embryo/fetus are provided in Rule
.1640 of this Section.

(b) The licensee or registrant shall make efforts to avoid
variation above a uniform monthly exposure rate to a declared pregnant woman so
as to satisfy the limit in Paragraph (a) of this Rule.

(c) The dose equivalent to an embryo/fetus shall be taken
as the sum of:

(1) the deep-dose equivalent to the declared
pregnant woman; and

(2) the dose equivalent to the embryo/fetus
from radionuclides in the embryo/fetus and radionuclides in the declared
pregnant woman.

(d) If the dose equivalent to the embryo/fetus is found to
have exceeded 0.45 rem (4.5 mSv) by the time the woman declares the pregnancy
to the licensee or registrant, the licensee or registrant shall be deemed to be
in compliance with Paragraph (a) of this Rule if the additional dose to the
embryo/fetus does not exceed 0.05 rem (0.5 mSv) during the remainder of the
pregnancy.

(1) The total effective dose equivalent to
individual members of the public from the licensed or registered operation does
not exceed 0.1 rem (1 mSv) in a year exclusive of the dose contribution from
background radiation from the licensee's disposal of radioactive material into
sanitary sewerage in accordance with Rule .1630 of this Section, from any
medical administration the individual has received, from exposure to
individuals administered radioactive material and released in accordance with
Rule .0358 of this Chapter and from voluntary participation in medical research
programs; and

(2) The dose in any unrestricted area from
external sources of radiation, exclusive of the dose contribution from patients
administered radioactive material and released in accordance with Rule .0358 of
this Chapter, does not exceed 0.002 rem (0.02 mSv) in any one hour.

(b) If the licensee or registrant permits members of the
public to have access to controlled areas, the limits for members of the public
continue to apply to those individuals.

(c) A licensee, registrant, license applicant or
registration applicant may apply for and must receive agency authorization to
operate up to an annual dose limit for an individual member of the public of
0.5 rem (5 mSv). The licensee, registrant, license applicant or registration
applicant shall include the following information in this application:

(1) demonstration of the need for and the
expected duration of operations in excess of the limit in Paragraph (a) of this
Rule;

(2) the licensee's program to assess and
control dose within the 0.5 rem (5 mSv) annual limit; and

(3) the procedures to be followed to maintain
the dose as low as is reasonably achievable.

(d) The agency may impose additional restrictions on
radiation levels in unrestricted areas and on the total quantity of
radionuclides that a licensee may release in effluents in order to maintain the
collective dose as low as reasonably achievable.

(e) Notwithstanding Subparagraph (a)(1) of this Rule, a
licensee may permit visitors to an individual who cannot be released in
accordance with Rule .0358 of this Section to receive a dose in excess of 0.1
rem (1 mSv) if:

(1) The radiation dose received does not exceed
0.5 rem (5 mSv); and

(2) The authorized user, as defined in Section
.0300 of this Chapter had determined before the visit that it is appropriate.

10A NCAC 15 .1612 COMPLIANCE WITH DOSE LIMITS FOR
MEMBERS OF THE PUBLIC

(a) The licensee or registrant shall make or cause to be
made, as appropriate, surveys of radiation levels in unrestricted and
controlled areas and measurements and surveys of radioactive materials in
effluents released to unrestricted and controlled areas to demonstrate
compliance with the dose limits for individual members of the public in Rule
.1611 of this Section.

(b) A licensee or registrant shall show compliance with the
annual dose limit in Rule .1611 of this Section by:

(1) demonstrating by measurement or calculation
that the total effective dose equivalent to the individual likely to receive
the highest dose from the licensed or registered operation does not exceed the
annual dose limit; or

(2) demonstrating that:

(A) The annual average concentrations of radioactive
material released in gaseous and liquid effluents at the boundary of the
unrestricted area do not exceed the values specified in Table 2 of Appendix B
to 10 CFR §§ 20.1001 - 20.2401; and

(B) If an individual were continually present in an
unrestricted area, the dose from external sources of radiation would not exceed
0.002 rem (0.02 mSv) in an hour and 0.05 rem (0.5 mSv) in a year.

(c) Upon approval from the agency, the licensee may adjust
the effluent concentration values in Appendix B to 10 CFR §§ 20.1001 - 20.2401,
Table 2, for members of the public, to take into account the actual physical
and chemical characteristics of the effluents (e.g., aerosol size distribution,
solubility, density, radioactive decay equilibrium, chemical form).

(a) Licensees and registrants shall conduct surveys, and
monitor for radiation and radiation exposure in accordance with the provisions
of 10 CFR 20.1501.

(b) The exposure of individual monitoring devices,
individual monitoring equipment, or personnel monitoring equipment to radiation
from any source for the purpose of falsifying exposure records shall be
prohibited.

(c) Notwithstanding Rule .0117 of this Chapter, the
regulations cited in this Rule from 10 CFR Chapter I (2015) are hereby
incorporated by reference, excluding subsequent amendments and editions. Copies
of these regulations are available free of charge at
http://www.ecfr.gov/cgi-bin/text-idx?SID=2beeece594411a03e50b2468ae31f89b&pitd=20160101&tpl=/ecfrbrowse/Title10/10tab_02.tpl.

Each licensee or registrant shall monitor exposures to
radiation and radioactive material at levels sufficient to demonstrate
compliance with the occupational dose limits of this Section. As a minimum:

(1) Each licensee or registrant shall monitor
occupational exposure to radiation and shall supply and require the use of
individual monitoring devices by:

(a) adults likely to receive, in one year from
sources external to the body, a dose in excess of 10 percent of the limits in
Rule .1604(a) of this Section;

(b) minors likely to receive, in one year, from
sources of radiation, a deep dose equivalent in excess of 0.1 rem (1 mSv), a
lens dose equivalent in excess of 0.15 rem (1.5 mSv), or a shallow dose
equivalent in excess of 0.5 rem (5 mSv);

(c) declared pregnant women likely to receive,
during the entire pregnancy, from sources of radiation external to the body, a
deep dose equivalent in excess of 0.1 rem (1 mSv); and

(d) individuals entering a high or very high
radiation area.

(2) Each licensee shall monitor the occupational intake
of radioactive material by and assess the committed effective dose equivalent
to:

(a) adults likely to receive, in one year, an
intake in excess of 10 percent of the applicable ALI(s) in Table 1, Columns 1
and 2, of Appendix B to 10 CFR 20.1001 - 20.2402; and

(b) minors likely to receive, in one year, a
committed effective dose equivalent in excess of 0.1 rem (1mSv); and

(a) The licensee or registrant shall ensure that each
entrance or access point to a high radiation area has at least one of the
following features:

(1) a control device that, upon entry into the
area, causes the level of radiation to be reduced below that level at which an
individual might receive a deep-dose equivalent of 0.1 rem (1 mSv) in one hour
at 30 centimeters from the radiation source or from any surface that the
radiation penetrates;

(2) a control device that energizes a
conspicuous visible or audible alarm signal so that the individual entering the
high radiation area and the supervisor of the activity are made aware of the
entry; or

(3) entryways that are locked, except during
periods when access to the areas is required, with positive control over each
individual entry.

(b) In place of the controls required by Paragraph (a) of
this Rule for a high radiation area, the licensee or registrant may substitute
continuous direct or electronic surveillance that is capable of preventing
unauthorized entry.

(c) Any licensee, registrant or applicant for a license or
registration may apply to the agency for approval of alternative methods for
controlling access to high radiation areas. The agency will approve
alternatives if the licensee, registrant or applicant demonstrates that the
alternative methods of control will prevent unauthorized entry into a high
radiation area.

(d) The licensee or registrant shall establish the controls
required by Paragraphs (a) and (c) of this Rule in a way that does not prevent
individuals from leaving a high radiation area.

(e) Control is not required for each entrance or access
point to a room or other area that is a high radiation area solely because of
the presence of radioactive materials prepared for transport and packaged and
labeled in accordance with the regulations of the U.S. Department of
Transportation provided that:

(1) the packages do not remain in the area
longer than three days; and

(2) the dose rate at one meter from the
external surface of any package does not exceed 0.01 rem (0.1 mSv) per hour.

(f) Control of entrance or access to rooms or other areas
in hospitals is not required solely because of the presence of patients
containing radioactive material, provided that there are personnel in
attendance who will take the necessary precautions to prevent the exposure of
individuals to radiation or radioactive material in excess of the limits
established in this Section and to operate within the ALARA provisions of the
licensee's radiation protection program.

In addition to the requirements in Rule .1615 of this
Section, the licensee or registrant shall also institute the additional
measures required in Rule .1617 of this Section to ensure that an individual is
not able to gain unauthorized or inadvertent access to very high radiation
areas.

(a) Each area in which there may exist radiation levels in
excess of 500 rads (5 grays) in one hour at one meter from a source of
radiation that is used to irradiate materials shall meet the following
requirements:

(1) Each entrance or access point shall be
equipped with entry control devices which:

(A) function automatically to prevent any individual
from inadvertently entering the area when very high radiation levels exist;

(B) permit deliberate entry into the area only after a
control device is actuated that causes the radiation level within the area,
from the source of radiation, to be reduced below that at which it would be
possible for an individual to receive a deep-dose equivalent in excess of 0.1
rem (1 mSv) in one hour; and

(C) prevent operation of the source of radiation if the
source would produce radiation levels in the area that could result in a
deep-dose equivalent to an individual in excess of 0.1 rem (1 mSv) in one hour.

(2) Additional control devices shall be
provided so that, upon failure of the entry control devices to function as
required by Subparagraph (a)(1) of this Rule:

(A) The radiation level within the area, from the source
of radiation, is reduced below that at which it would be possible for an
individual to receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in
one hour; and

(B) Conspicuous visible and audible alarm signals are
generated to make an individual attempting to enter the area aware of the hazard
and at least one other authorized individual, who is physically present,
familiar with the activity, and prepared to render or summon assistance, aware
of the failure of the entry control devices.

(3) The licensee or registrant shall provide
control devices so that, upon failure or removal of physical radiation barriers
other than the shielded storage container:

(A) The radiation level from the source of radiation is
reduced below that at which it would be possible for an individual to receive a
deep-dose equivalent in excess of 0.1 rem (1 mSv) in one hour; and

(B) Conspicuous visible and audible alarm signals are
generated to make potentially affected individuals aware of the hazard and the
licensee or registrant or at least one other individual, who is familiar with
the activity and prepared to render or summon assistance, aware of the failure
or removal of the physical barrier.

(4) When the shield for the stored source of
radiation is a liquid, the licensee or registrant shall provide means to
monitor the integrity of the shield and to signal, automatically, loss of
adequate shielding.

(5) Physical radiation barriers that comprise
permanent structural components, such as walls, that have no credible
probability of failure or removal in ordinary circumstances need not meet the
requirements of Subparagraphs (a)(3) and (4) of this Rule.

(6) Each area shall be equipped with a clearly
identified control device which can prevent the source of radiation from being
put into operation.

(7) Each area shall be equipped with devices
that will automatically generate conspicuous visible and audible alarm signals
to alert personnel in the area before the source of radiation can be put into
operation and in sufficient time for any individual in the area to operate the
control device required by Subparagraph (a)(6) of this Rule.

(8) Each area shall be controlled by use of
such administrative procedures and such devices as are necessary to ensure that
the area is cleared of personnel prior to each use of the source of radiation.

(9) Each area shall be checked by a radiation
measurement to ensure that, prior to the first individual's entry into the area
after any use of the source of radiation, the radiation level from the source
in the area is below that at which it would be possible for an individual to
receive a deep-dose equivalent in excess of 0.1 rem (1 mSv) in one hour.

(10) The entry control devices required in
Subparagraph (a)(1) of this Rule shall have been tested for proper
functioning. Recordkeeping requirements relating to these tests are provided
in Rule .1643 of this Section.

(A) Testing shall be conducted prior to initial
operation of the source of radiation on any day, unless operations were
continued uninterrupted from the previous day;

(B) Testing shall be conducted prior to resumption of
operation of the source of radiation after any unintended interruption; and

(C) The licensee or registrant shall submit and adhere
to a schedule for periodic tests of the entry control and warning systems.

(11) The licensee or registrant shall not conduct
operations, other than those necessary to place the source of radiation in safe
condition or to effect repairs on controls, unless control devices are
functioning properly.

(12) Entry and exit portals that are used in
transporting materials to and from the irradiation area, and that are not
intended for use by individuals, shall be controlled by such devices and
administrative procedures as are necessary to physically protect and warn
against inadvertent entry by any individual through these portals. Exit
portals for processed materials shall be equipped to detect and signal the
presence of any loose radiation sources that are carried toward such an exit
and to automatically prevent loose radiation sources from being carried out of
the area.

(b) Any licensee, registrant or applicant for a license or
registration for sources of radiation that are subject to Paragraph (a) of this
Rule and that will be used in a variety of positions or in locations, such as
open fields or forests, that make it impracticable to comply with certain
requirements of Paragraph (a) of this Rule, such as those for the automatic
control of radiation levels, may apply to the agency for approval of the use of
alternative safety measures. Any alternative safety measures shall provide a
degree of personnel protection at least equivalent to those specified in
Paragraph (a) of this Rule. At least one of the alternative measures shall
include an entry-preventing interlock control based on a measurement of the radiation
that ensures the absence of high radiation levels before an individual can gain
access to the area where such radiation sources are used.

(c) The entry control devices required by Paragraphs (a)
and (b) of this Rule shall be established in such a way that no individual will
be prevented from leaving the area.

(d) This Rule applies to radiation from non-self-shielded
irradiators. This Rule does not apply to sources of radiation that are used in
therapy, in radiography, or in completely self-shielded irradiators in which
the source of radiation is both stored and operated within the same shielding
radiation barrier and, in the designed configuration of the irradiator, is
always physically inaccessible to any individual and cannot create high levels
of radiation in an area that is accessible to any individual. This Rule also
does not apply to sources of radiation from which the radiation is incidental
to some other use.

The licensee shall use, to the extent practicable, process
or other engineering controls (e.g., containment, decontamination, or
ventilation) to control the concentrations of radioactive material in air.

(a) When it is not practicable to apply process or other
engineering controls to control the concentrations of radioactive material in
air to values below those that define an airborne radioactivity area, the
licensee shall, consistent with maintaining the total effective dose equivalent
ALARA, increase monitoring and limit intakes of radionuclides by one or more of
the following means:

(1) the control of access to the area;

(2) the limitation of exposure times of personnel in
the area;

(3) the use of respiratory protection equipment; or

(4) other controls.

(b) If the licensee performs ALARA analyses to determine
whether or not respirators are to be used, the licensee may consider safety
factors other than radiological factors. The licensee shall also consider the
impact of respirator use on workers' industrial health and safety.

(1) use respiratory protection equipment that
is tested and certified by the National Institute for Occupational Safety and
Health (NIOSH);

(2) if the licensee wishes to use any equipment
that has not been tested or certified by NIOSH, or for which there is no
schedule for testing or certification, submit an application to the agency for
authorized use of that equipment, including a demonstration by testing, or a
demonstration on the basis of reliable test information, that the material and
performance characteristics of the equipment are capable of providing the proposed
degree of protection under anticipated conditions of use;

(3) implement and maintain a respiratory
protection program that includes:

(B) surveys and bioassays, as appropriate, to evaluate
actual intakes;

(C) testing of respirators for operability immediately
prior to each use;

(D) written procedures regarding: monitoring, including
air sampling and bioassays; supervision and training of respirator users; fit
testing; respirator selection; breathing air quality; inventory and control;
storage, issuance, maintenance, repair, testing, and quality assurance of
respiratory protection equipment; recordkeeping; and limitations on periods of
respirator use and relief from respirator use;

(E) determination by a physician prior to initial
fitting of a face sealing respirator, prior to the first field use of a
non-face sealing respirator, and at least every 12 months thereafter or
periodically at a frequency determined by a physician, that the individual user
is physically able to use the respiratory protection equipment; and

(F) Fit testing, with fit factor ³ 10 times the APF for negative pressure
devices, and a fit factor ³ 500 for any
positive pressure, continuous flow, and pressure-demand devices, before the
first field use of tight fitting, face sealing respirators and annually
thereafter. Fit testing must be performed with the facepiece operating in the
negative pressure mode.

(4) advise each respirator user that the user
may leave the area at any time for relief from respirator use in the event of
equipment malfunction, physical or psychological distress, procedural or
communication failure, significant deterioration of operating conditions, or
any other conditions that might require such relief;

(5) use equipment within limitations for type
and mode of use and provide for vision correction, effective communication, low
temperature work environments, the concurrent use of other safety or radiological
protection equipment, and assurance that other such equipment will be used in
such a way as not to interfere with proper operation of the respirator.

(6) provide standby rescue personnel whenever
one-piece atmosphere-supplying suits, or any combination of supplied air
respiratory protection devices and personnel protective equipment are used from
which an unaided individual would have difficulty extricating himself or
herself. The standby rescue personnel shall:

(A) be equipped with
respiratory protection devices or other apparatus appropriate for the potential
hazards identified by the licensee;

(B) observe or
otherwise maintain continuous communication with the workers through visual,
voice, signal line, telephone, radio, or other means suitable for the
environment;

(C) be immediately
available to assist workers in the event of a failure of the air supply or for
any other reason that requires relief from distress;

(D) be immediately
available in sufficient number to assist all users of this type of equipment
and to provide effective emergency rescue, if needed.

(7) provide atmosphere-supplying respirators
with respirable air of grade D quality or better as defined by the Compressed
Gas Association in publication G-7.1, "Commodity Specification for Air,"
1997 and included in Title 29 CFR 1910.134(i)(1)(ii)(A)  (E) of the
Occupational Safety and Health Administration. Grade D quality air criteria
include:

(A) Oxygen content of
19.5% - 23.5%;

(B) condensed
Hydrocarbon content of 5 milligrams per cubic meter of air or less;

(C) Carbon Monoxide
(CO) content of 10 ppm or less;

(D) Carbon Dioxide
content of 1,000 ppm or less; and

(E) lack of
noticeable odor.

(8) ensure that no objects, materials or
substances, such as facial hair, or any conditions that interfere with the
face-to-facepiece seal or valve function, and that are under the control of the
respirator wearer, are present between the skin of the wearer's face and the
sealing surface of a tight-fitting respirator facepiece.

(b) In estimating the dose to individuals from intake of
airborne radioactive materials, the concentration of radioactive material in
the air that is inhaled when respirators are worn is initially assumed to be
the ambient concentration in air without respiratory protection, divided by the
assigned protection factor. If the dose is later found to be greater than the
estimated dose, the corrected value must be used. If the dose is later found
to be less than the estimated dose, the corrected value may be used.

(c) The licensee shall obtain authorization, in writing,
from the agency before using assigned protection factors in excess of those
specified in Appendix A to 10 CFR Part 20. The agency may authorize the use of
higher assigned protection factors upon receipt of an application that:

(1) describes the
situation for which a need exists for higher protection factors; and

(2) demonstrates
that the respiratory equipment provides the higher protection factors under the
proposed conditions of use.

10A NCAC 15 .1621 RESTRICTIONS ON THE USE OF RESPIRATORY
PROTECTION EQUIPMENT

The agency may impose restrictions in addition to those in
Rules .1619 and .1620 of this Section, and Appendix A to 10 CFR 20.1001 -
20.2401 when the agency determines that such requirements are necessary to:

(1) ensure that the respiratory protection program of
the licensee is adequate to limit exposures of individuals to airborne
radioactive materials to levels that maintain the total effective dose
equivalent ALARA; and

(2) limit the extent to which a licensee may use
respiratory protection equipment instead of process or other engineering
controls when process or other engineering controls are appropriate to limit
exposures of individuals to airborne radioactive materials to the levels
prescribed in this Section.

(a) Unless otherwise authorized by the agency, the symbol
prescribed by the rules of this Chapter shall use the colors magenta, or
purple, or black on yellow background. The radiation symbol prescribed by the
rules of this Chapter is the standard three-bladed design.

(1) The blades and interior circle shall be
magenta, purple, or black; and

(2) The background shall be yellow.

(b) Notwithstanding the requirements of Paragraph (a) of
this Rule, licensees and registrants are authorized to label sources, source
holders, or device components containing sources of radiation that are
subjected to high temperatures, with conspicuously etched or stamped radiation
caution symbols and without a color requirement.

(c) In addition to the contents of signs and labels
prescribed in the rules of this Chapter, the licensee or registrant may
provide, on or near the required signs and labels, additional information, as
appropriate, to make individuals aware of potential radiation exposures and to
minimize the exposures.

(a) The licensee or registrant shall post each radiation
area with a conspicuous sign or signs bearing the radiation symbol and the
words:

CAUTION

RADIATION AREA

(b) The licensee or registrant shall post each high
radiation area with a conspicuous sign or signs bearing the radiation symbol
and the words:

CAUTION

HIGH RADIATION
AREA

or the words:

DANGER

HIGH RADIATION
AREA

(c) The licensee or registrant shall post each very high
radiation area with a conspicuous sign or signs bearing the radiation symbol
and words:

GRAVE DANGER

VERY HIGH
RADIATION AREA

(d) The licensee shall post each airborne radioactivity
area with a conspicuous sign or signs bearing the radiation symbol and the
words:

CAUTION

AIRBORNE RADIOACTIVITY
AREA

or the words:

DANGER

AIRBORNE
RADIOACTIVITY AREA

(e) The licensee shall post each area or room in which
there is used or stored an amount of licensed radioactive material exceeding 10
times the quantity of such material specified in Appendix C to 10 CFR §§
20.1001 - 20.2401 with a conspicuous sign or signs bearing the radiation symbol
and the words:

(a) A licensee is not required to post caution signs in
areas or rooms containing radioactive materials for periods of less than eight
hours, if each of the following conditions is met:

(1) The materials are constantly attended
during these periods by an individual who takes the precautions necessary to
prevent the exposure of individuals to radiation or radioactive materials in
excess of the limits established in the rules in this Section; and

(2) The area or room is subject to the
licensee's control.

(b) Rooms or other areas in hospitals that are occupied by
patients are not required to be posted with caution signs pursuant to Rule
.1624 of this Section provided that:

(1) The patient is being treated with sealed
sources or has been treated with unsealed radioactive material in quantities
less than 30 millicuries (110 MBq), or the measured dose rate at one meter from
the patient is less than 0.005 rem (0.05 mSv) per hour; and

(2) There are personnel in attendance who will
take the necessary precautions to prevent the exposure of individuals to
radiation or radioactive material in excess of the limits established in this
Section and to operate within the ALARA provisions of the licensee's radiation
protection program.

(c) A room or area is not required to be posted with a
caution sign because of the presence of a sealed source provided the radiation
level at 30 centimeters from the surface of the source container or housing
does not exceed 0.005 rem (0.05 mSv) per hour.

(d) Rooms or other areas in medical facilities that are
occupied by patients while being treated with radiation from an accelerator are
not required to be posted with a caution sign pursuant to Rule .1624(c) of this
Section provided that:

(1) access to the room or area is posted in
accordance with Rule .1624(b) of this Section; and

(2) there are personnel in attendance who shall
provide assurance that:

(A) continuous audio and visual observation of the
patient is maintained during treatment;

(B) all provisions of Subparagraph (b)(2) of this Rule
are met; and

(C) the accelerator is secured in the "beam
off" status at the end of each patient's treatment.

(e) Rooms or other areas in medical facilities that are
occupied by patients while being treated with radiation from a teletherapy
source are not required to be posted with a caution sign pursuant to Rule
.1624(c) of this Section provided that:

(1) access to the room or area is posted in
accordance with Rule .1624(b) of this Section; and

(2) there are personnel in attendance who shall
take the necessary precautions to prevent the inadvertent exposures of workers,
other patients, and members of the public to radiation in excess of the limits
established in the rules of this Section.

History Note: Authority G.S. 104E-7(a)(2);

Eff. January 1, 1994;

Temporary Amendment Eff. August 20, 1994 for a period of
180 days or until the permanent rule becomes effective, whichever is sooner;

(1) each container of licensed radioactive
material bears a durable, visible label bearing the radiation symbol and the
words:

(A) CAUTION

RADIOACTIVE MATERIAL; or

(B) DANGER

RADIOACTIVE MATERIAL

The label shall also
provide sufficient information (such as the radionuclide(s) present, an
estimate of the quantity of radioactivity, the date for which the activity is
estimated, radiation levels, kinds of materials, and mass enrichment) to permit
individuals handling or using the containers, or working in the vicinity of the
containers, to take precautions to avoid or minimize exposures; and

(2) each syringe and vial that contains
unsealed radioactive material for medical use is labeled to identify the
radioactive drug. Each syringe shield and vial shield must also be labeled
unless the label on the syringe or vial is visible when shielded.

(b) Each licensee shall, prior to removal or disposal of
empty uncontaminated containers to unrestricted areas, remove or deface the
radioactive material label or otherwise indicate that the container no longer
contains radioactive materials.

(c) Except as required in Subparagraph (a)(2) of this Rule,
a licensee is not required to label:

(3) containers attended by an individual who
takes the precautions to prevent the exposure of individuals in excess of the
limits established by this Section;

(4) containers when they are in transport and
packaged and labeled in accordance with the regulations of the U.S. Department
of Transportation;

(5) containers that are accessible only to
individuals authorized to handle or use them or to work in the vicinity of the containers
if the contents are identified to these individuals by a readily available
written record (for example, containers in locations such as water-filled
canals, storage vaults, or hot cells, provided the record shall be retained as
long as the containers are in use for the purpose indicated on the record); or

(6) installed manufacturing or process
equipment, such as piping and tanks.

(a) Each licensee who expects to receive a package
containing quantities of radioactive material in excess of a Type A quantity,
as defined in Rule .0104 of this Chapter, shall make arrangements to receive:

(1) the package when the carrier offers it for
delivery; or

(2) notification of the arrival of the package
at the carrier's terminal and to take possession of the package expeditiously.

(b) Each licensee, upon receipt of a package containing
radioactive material, shall monitor:

(1) external surfaces of a package labeled as
containing radioactive material for radioactive contamination unless the
package contains only radioactive material in the form of a gas or in special
form as defined in 10 C.F.R 71.4;

(2) external surfaces of a package labeled as
containing radioactive material for radiation levels unless the package
contains quantities of radioactive material that are less than or equal to the
Type A quantity, as defined in 10 C.F.R 71.4 and Appendix A to Part 71; and

(3) all packages known to contain radioactive
material for radioactive contamination and radiation levels if there is
evidence of degradation of package integrity, such as packages that are
crushed, wet, or damaged.

(c) The licensee shall perform the monitoring required by
Paragraph (b) of this Rule as soon as practicable after receipt of the package,
but not later than three hours after the package is received at the licensee's
facility if it is received during the licensee's normal working hours, or not
later than three hours from the beginning of the next working day if it is
received after working hours.

(d) The licensee shall immediately notify the final
delivery carrier and, by telephone and telegram, mailgram, or facsimile, the
agency when:

(1) establish, maintain, and retain written
procedures for safely opening packages in which radioactive material is
received; and

(2) ensure that the procedures are followed and
that due consideration is given to special instructions for the type of package
being opened.

(f) Licensees transferring special form sources in
licensee-owned or licensee-operated vehicles to and from a work site are exempt
from the contamination monitoring requirements of Paragraph (b) of this Rule,
but are not exempt from the survey requirement in Paragraph (b) of this Rule
for measuring radiation levels that is required to ensure that the source is
still properly lodged in its shield.

A licensee or applicant for a license may apply to the
agency for approval of proposed procedures, not otherwise authorized in this
Section, to dispose of licensed radioactive material generated in the
licensee's activities. Each application shall include:

(1) a description of the waste containing licensed
radioactive material to be disposed of, including the physical and chemical
properties important to risk evaluation, and the proposed manner and conditions
of waste disposal;

(2) an analysis and evaluation of pertinent information
on the nature of the environment;

(3) the nature and location of other potentially
affected licensed and unlicensed facilities; and

(4) analyses and procedures to ensure that doses are
maintained ALARA and within the dose limits in this Section.

(a) A licensee may discharge licensed radioactive material
into sanitary sewerage if each of the following conditions is satisfied:

(1) The material is readily soluble in water or
is biological material that is readily dispersible in water; and

(2) The quantity of licensed or other
radioactive material that the licensee releases into the sewer in one month
divided by the average monthly volume of water released into the sewer by the
licensee does not exceed the concentration listed in Table 3 of Appendix B to
10 CFR §§ 20.1001 - 20.2401; and

(3) If more than one radionuclide is released,
the following conditions shall also be satisfied:

(A) The licensee shall determine the fraction of the
limit in Table 3 of Appendix B to 10 CFR §§ 20.1001 - 20.2401 represented by
discharges into sanitary sewerage by dividing the actual monthly average
concentration of each radionuclide released by the licensee into the sewer by
the concentration of that radionuclide listed in Table 3 of Appendix B to 10
CFR §§20.1001 - 20.2401; and

(B) The sum of the fractions for each radionuclide
required by Part (a)(3)(A) of this Rule does not exceed unity; and

(4) The total quantity of licensed and other
radioactive material that the licensee releases into the sanitary sewerage
system in a year does not exceed five curies (185 GBq) of hydrogen-3, one curie
(37 GBq) of carbon-14, and one curie (37 GBq) of all other radioactive
materials combined.

(b) Excreta from individuals undergoing medical diagnosis
or therapy with radioactive material is not subject to the limitations
contained in Paragraph (a) of this Rule.

A licensee may treat or dispose of licensed radioactive
material by incineration only in the amounts and forms specified in Rule .1632
or as specifically approved by the agency pursuant to Rule .1629 of this
Section.

(a) The requirements of this Rule and Appendix G to 10 CFR Part
20, incorporated by reference in Rule .0117 of this Chapter, are designed to:

(1) control transfers of low-level radioactive
waste by any waste generator, waste collector, or waste processor licensee, as
defined in Appendix G to 10 CFR Part 20, who ships low-level waste either
directly, or indirectly through a waste collector or waste processor, to a
licensed low-level waste disposal facility, as defined in Rule .1202 of this
Chapter;

(b) Any licensee shipping radioactive waste intended for
ultimate disposal at a licensed land disposal facility shall document the
information required on the U.S. Nuclear Regulatory Commission's Uniform
Low-Level Radioactive Waste Manifest and transfer this recorded manifest
information to the intended consignee in accordance with this Rule and Appendix
G to 10 CFR Part 20.

(c) Each shipment manifest shall include a certification by
the waste generator as specified in Appendix G to 10 CFR Part 20.

(d) Each person involved in the transfer for disposal and
disposal of waste, including the waste generator, waste collector, waste
processor, and disposal facility operator, shall comply with the requirements
specified in this Rule and Appendix G to 10 CFR Part 20.

(e) Reports and notifications required to be made to the
nearest regional administrator by Appendix G to 10 CFR Part 20 shall be made to
the agency instead.

(f) Any licensee shipping radioactive material as defined
in Rule .0104 of this Chapter intended for ultimate disposal at a land disposal
facility as defined in Rule .1202 of this Chapter must document the information
required on the U.S. Nuclear Regulatory Commission's Uniform Low-Level
Radioactive Waste Manifest and transfer this recorded manifest information to
the intended consignee in accordance with appendix G to 10 CFR Part 20.

(g) Radioactive material as defined in Rule .0104 of this
Chapter may be disposed of in accordance with Rule .1628 of this Section. Any
licensed radioactive material being disposed of at a facility, or transferred
for ultimate disposal at a facility licensed under 10 CFR Part 61, must meet
the requirements of this Rule.

(h) A licensee may dispose of radioactive material as
defined in Rule .0104 of this Chapter at a disposal facility authorized to
dispose of such material in accordance with any Federal or State solid or
hazardous waste law, including the Solid Waste Disposal Act established by the
Energy Policy Act of 2005.

Nothing in this Section relieves the licensee from complying
with other applicable federal, state, and local regulations governing any other
toxic or hazardous properties of materials that may be disposed of under this
Section.

(a) Each licensee or registrant shall use the units: curie,
rad and rem, including multiples and subdivisions thereof, and shall clearly
indicate the units of all quantities on records required by this Section.

(b) Notwithstanding the requirements of Paragraph (a) of
this Rule, when recording information on shipping manifests, as required by
Rule .1633 of this Section and Appendix G to 10 CFR 20, information shall be
recorded in the International System of Units (SI) or SI and units as specified
in Paragraph (a) of this Rule. For records other than shipping manifests, the
licensee or registrant may record quantities in SI units in parenthesis
following each of the units specified in Paragraph (a) of this Rule; however
all quantities shall be recorded as stated in Paragraph (a) of this Rule.

(c) The licensee or registrant shall make a clear
distinction whether the quantities entered on the records required by this
Section are total effective dose equivalent, shallow-dose equivalent, eye dose
equivalent, deep-dose equivalent, or committed effective dose equivalent.

(d) The discontinuance or curtailment of activities does
not relieve the licensee or registrant of responsibility for retaining all
records required by the rules in this Section.

(b) The licensee or registrant shall retain the records
required by Subparagraph (a)(1) of this Rule until the agency terminates each
pertinent license or registration requiring the record. The licensee or
registrant shall retain the records required by Subparagraph (a)(2) of this
Rule for three years after the record is made.

(a) Each licensee or registrant shall maintain records
showing the results of surveys and calibrations required by Rules .1613 and
.1627(b) of this Section. The licensee or registrant shall retain these
records for three years after the record is made.

(b) The licensee or registrant shall retain each of the
following records until the agency terminates each pertinent license or
registration requiring the record:

(1) records of the results of surveys to
determine the dose from external sources and used, in the absence of or in
combination with individual monitoring data, in the assessment of individual
dose equivalents;

(2) records of the results of measurements and
calculations used to determine individual intakes of radioactive material and
used in the assessment of internal dose;

(3) records showing the results of air
sampling, surveys, and bioassays required pursuant to Rule .1620(a) of this
Section; and

(4) Records of the results of measurements and
calculations used to evaluate the release of radioactive effluents to the
environment.

(a) For each individual who may enter the licensee's or
registrant's restricted or controlled area and is likely to receive, in a year,
an occupational dose requiring monitoring pursuant to Rule .1614 of this
Section, the licensee or registrant shall:

(1) determine the occupational radiation dose
received during the current year; and

(b) Prior to permitting an individual to participate in a
planned special exposure, the licensee or registrant shall determine:

(1) the internal and external doses from all
previous planned special exposures; and

(2) all doses in excess of the limits received
during the lifetime of the individual, including doses received during
accidents and emergencies.

(c) In complying with the requirements of Paragraph (a) of
this Rule, a licensee or registrant may:

(1) accept, as a record of the occupational
dose that the individual received during the current year, a written signed
statement from the individual, or from the individual's most recent employer
for work involving radiation exposure, that discloses the nature and the amount
of any occupational dose that the individual may have received during the
current year;

(2) accept, as the record of lifetime
cumulative radiation dose, an up-to-date agency form for recording occupational
radiation dose history, or equivalent, signed by the individual and
counter-signed by an appropriate official of the most recent employer for work
involving radiation exposure, or the individual's current employer if the
individual is not employed by the licensee or registrant; or

(3) obtain reports of the individual's dose
equivalent(s) by telephone, telegram, electronic media, or letter from the most
recent employer for work involving radiation exposure, or the individual's
current employer if the individual is not employed by the licensee or
registrant. The licensee or registrant shall request a written verification of
the dose data if the authenticity of the transmitted report cannot be
established.

(d) The licensee or registrant shall record the exposure
history, as required by Paragraph (a) of this Rule, on the agency form for
recording occupational radiation dose history, or other clear and legible
record of all the information required on that form. The form or record shall
show each period in which the individual received occupational exposure to
radiation or radioactive material and shall be signed by the individual who
received the exposure. For each period for which the licensee or registrant
obtains reports, the licensee or registrant shall use the dose shown in the
report in preparing the agency form for recording occupational radiation dose
history. For any period in which the licensee or registrant does not obtain a
report, the licensee or registrant shall place a notation on the agency form
for recording occupational radiation dose history indicating the periods of
time for which data are not available. Licensees or registrants are not
required to reevaluate the separate external dose equivalents and internal
committed dose equivalents or intakes of radionuclides assessed prior to
January 1, 1994 under Section .0400 of this Chapter. Further, occupational
exposure histories obtained and recorded before January 1, 1991, may not have
included effective dose equivalent, but may be used in the absence of specific
information on the intake of radionuclides by the individual.

(e) If the licensee or registrant is unable to obtain a
complete record of an individual's current and previously accumulated
occupational dose, the licensee or registrant shall assume:

(1) in establishing administrative controls
under Rule .1604(f) of this Section for the current year, that the allowable
dose limit for the individual is reduced by 1.25 rems (12.5 mSv) for each
quarter for which records were unavailable and the individual was engaged in
activities that could have resulted in occupational radiation exposure; and

(2) that the individual is not available for
planned special exposures.

(f) The licensee or registrant shall retain the records on
the agency form for recording occupational radiation dose history or equivalent
until the agency terminates each pertinent license or registration requiring
this record. The licensee or registrant shall retain records used in preparing
the agency form for recording occupational radiation dose history for three
years after the record is made.

(a) Each licensee or registrant shall maintain records of
doses received by all individuals for whom monitoring was required pursuant to
Rule .1614 of this Section, and records of doses received during planned
special exposures, accidents, and emergency conditions. These records shall
include, when applicable:

(1) the deep-dose equivalent to the whole body,
eye dose equivalent, shallow-dose equivalent to the skin, and shallow-dose
equivalent to the extremities;

(2) the estimated intake of radionuclides (see
Rule .1605 of this Section);

(3) the committed effective dose equivalent
assigned to the intake or body burden of radionuclides;

(4) the specific information used to calculate
the committed effective dose equivalent pursuant to Rule .1607(c) of this
Section and when required by Rule .1614 of this Section;

(5) the total effective dose equivalent when
required by Rule .1605 of this Section; and

(6) the total of the deep-dose equivalent and
the committed dose to the organ receiving the highest total dose.

(b) The licensee or registrant shall make entries of the
records specified in Paragraph (a) of this Rule at least annually.

(c) The licensee or registrant shall maintain the records
specified in Paragraph (a) of this Rule on the agency form for recording
occupational radiation doses, in accordance with the instructions provided with
the form, or in clear and legible records containing all the information
required by the agency form for recording occupational radiation doses.

(d) Assessments of dose equivalent and records made using
units in effect before the licensee's or registrant's implementation of the
rules in this Section need not be changed.

(e) The records required under this Rule may be protected
from public disclosure because of their personal privacy nature; however, the
limitations in this Paragraph are subject to, and do not limit federal and
state laws that may require disclosure.

(f) The licensee or registrant shall maintain the records
of dose to an embryo/fetus with the records of dose to the declared pregnant
woman. The declaration of pregnancy shall also be kept on file, but may be
maintained separately from the dose records.

(g) The licensee or registrant shall retain each required
form or record until the agency terminates each pertinent license or
registration requiring the record.

(a) Each licensee or registrant shall maintain records
sufficient to demonstrate compliance with the dose limit for individual members
of the public required by Rule .1611 of this Section. These records may
include such things as survey results, monitoring results, calculations and
other documents pertaining to the determination of doses to individual members
of the public.

(b) The licensee or registrant shall retain the records required
by Paragraph (a) of this Rule until the agency terminates each pertinent
license or registration requiring the record.